Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-25
Brief Title:
Positive Psychotherapy Balance Model Based Psychoeducation for Caregivers of Oncology Patients
Sponsor:
Servet CİHAN
Organization:
Prof Dr Cemil Tascıoglu Education and Research Hospital Organization
Study Overview
Official Title:
The Effect of Positive Psychotherapy Balance Model Based Psychoeducation on Balanced Life Psychological Well-Being and Self-Efficacy in Caregivers of Oncology Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study positive psychotherapy balance model applied to individuals caring for oncology patients the effect of psychoeducation intervention on balanced life psychological well-being and self-efficacy It will be carried out as a randomised control group experimental research with pretest-posttest follow-up The independent variable of the study is positive psychotherapy balance model based psychoeducation intervention The dependent variables are Balanced Life Scale Psychological Well-Being Scale Self-Efficacy Scale The control variables are the socio-demographic characteristics of the participants gender age educational status marital status etc and the characteristics related to the caregiving process duration of care time allocated for care etc
Hypothesis 1 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of balanced life
H11 Positive psychotherapy balance model based psychoeducation has an effect on increasing the level of success
H12 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of relationship
H13 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of futuremeaningspirituality
H14 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the body level
Hypothesis 2 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of psychological well-being
Hypothesis 3 Positive psychotherapy balance model based psychoeducation has an effect on increasing general self-efficacy level
Research data will be collected with data collection tools after obtaining ethics committee and institutional permission Psychoeducation based on the positive psychotherapy balance model will be carried out face-to-face with caregivers of individuals with colorectal cancer in a city hospital
The population of the study will consist of caregivers of individuals diagnosed with colorectal cancer in a city hospital The sample of the study was calculated by performing power analysis with GPower 3194 programme As a result of the power analysis based on a similar study for the research designed as a control and an intervention group the total sample size was calculated as 38 people in the groups of 19 people at the 85 Power 005 alpha significance level with the prediction that the difference in the medium effect size f025 between the groups in the pre and post evaluations for the two groups would be considered statistically significant Considering the possibility of caregivers dropping out or being excluded from the study it was decided to include 8 additional people 4 in each group A total of 46 caregivers in the intervention and control groups will constitute the sample of the study
Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined via the internet httpswwwrandomizerorg Group 1 Intervention Group Group 2 Control Group Afterwards they will be assigned to the groups in accordance with the order in the randomisation table The randomisation result will be indicated in the form of a table
Personal information form Balanced Life Scale Psychological Well-Being Scale and Self-Efficacy Scale will be used as data collection tools
Data collection tools will be applied to all caregivers who agree to participate in the study and meet the inclusion criteria and a brief information about the psychoeducation process will be given Psychoeducation based on Positive Psychotherapy Balance Model will be conducted in 5 sessions 5 weeks one day a week 90-120 minutes The control group will receive a one-session 60 minutes information training after 3 weeks
After all sessions are completed post-tests will be applied to the intervention group and the control group Follow-up data will be collected from the intervention and control groups 3 months after the psychoeducation programme is completed After the end of the study PPT Balance Model Based Psychoeducation will be given to the caregivers in the control group
Hypothesis 1 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of balanced life
H11 Positive psychotherapy balance model based psychoeducation has an effect on increasing the level of success
H12 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of relationship
H13 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of futuremeaningspirituality
H14 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the body level
Hypothesis 2 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of psychological well-being
Hypothesis 3 Positive psychotherapy balance model based psychoeducation has an effect on increasing general self-efficacy level
Research data will be collected with data collection tools after obtaining ethics committee and institutional permission Psychoeducation based on the positive psychotherapy balance model will be carried out face-to-face with caregivers of individuals with colorectal cancer in a city hospital
The population of the study will consist of caregivers of individuals diagnosed with colorectal cancer in a city hospital The sample of the study was calculated by performing power analysis with GPower 3194 programme As a result of the power analysis based on a similar study for the research designed as a control and an intervention group the total sample size was calculated as 38 people in the groups of 19 people at the 85 Power 005 alpha significance level with the prediction that the difference in the medium effect size f025 between the groups in the pre and post evaluations for the two groups would be considered statistically significant Considering the possibility of caregivers dropping out or being excluded from the study it was decided to include 8 additional people 4 in each group A total of 46 caregivers in the intervention and control groups will constitute the sample of the study
Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined via the internet httpswwwrandomizerorg Group 1 Intervention Group Group 2 Control Group Afterwards they will be assigned to the groups in accordance with the order in the randomisation table The randomisation result will be indicated in the form of a table
Personal information form Balanced Life Scale Psychological Well-Being Scale and Self-Efficacy Scale will be used as data collection tools
Data collection tools will be applied to all caregivers who agree to participate in the study and meet the inclusion criteria and a brief information about the psychoeducation process will be given Psychoeducation based on Positive Psychotherapy Balance Model will be conducted in 5 sessions 5 weeks one day a week 90-120 minutes The control group will receive a one-session 60 minutes information training after 3 weeks
After all sessions are completed post-tests will be applied to the intervention group and the control group Follow-up data will be collected from the intervention and control groups 3 months after the psychoeducation programme is completed After the end of the study PPT Balance Model Based Psychoeducation will be given to the caregivers in the control group
Detailed Description:
İntroduction and Objective Cancer is one of the leading chronic health problems in terms of mortality and morbidity all over the world accompanied by many symptoms requiring a long-term treatment process and requiring attentive care not only in the hospital but also in the home environment For an individual with a diagnosis of cancer the caregiver is involved in all physical emotional social spiritual and economic dimensions of patient care Caregivers are involved in the they play an important role in the care adaptation and management of the disease Struggling with a vital disease such as cancer is a serious physical economic and social challenge not only for the patient but also for the patients family and close environment especially in terms of mental health status affects in a sense The continuous and intensive nature of caregiving combined with other responsibilities in the life spheres of individuals caring for oncology patients turns into a dependent unidirectional intensive and long-term obligation that disrupts the care-giving-caregiving relationship distresses the caregivers life and creates a conflict between the care roles of the caregiver with family relationships entertainment work and social life roles Caregivers need to find a balance to resolve the conflict between the responsibilities of the care role and their own needs and demands However they benefit from limited training information and support in the caregiving role
The principle of balance which is one of the principles of positive psychotherapy argues that it is possible for individuals to cope with their conflicts by allocating their life energies to four areas in a balanced way In accordance with the principle of balance individuals should use the areas of body relationship success and futurespirituality in a balanced way in order to solve the problems they experience Because according to positive psychotherapy it is possible for individuals to have a fully healthy and productive life with the importance they will give to these four basic life dimensions and the balanced use of the time and energy they will spend In the context of positive psychotherapy an individual who has a balanced life goal and also has high general self-efficacy skills is expected to be more courageous and willing to show the necessary efforts to maintain a balanced life Because the individual with high general self-efficacy skills will have a strong belief in overcoming the problems heshe may encounter despite the effort heshe will make for a balanced life and thus the individual who has the desire to live a balanced life and can find the competence to make the necessary efforts will be able to keep hisher motivation high to continue hisher efforts as heshe sees the positive changes in hisher life with the steps heshe will take The concept of psychological well-being which focuses on the self-development and growth of the individual by realising hisher own meaning competence and capacity based on the individuals own self-powers and competencies is the natural result of the process experienced by the individual aiming for such a life at this point In this direction it can be said that adopting a loving connected and balanced state of mind in the face of the difficulties experienced by caregivers and the responsibilities they undertake will increase the joy meaning self-sufficiency in life and as a result may contribute positively to their level of well-being All these results help caregivers to recognise their own resources maintain their life balance and adopt a positive perspective towards themselves
Materials and Methods In this study positive psychotherapy balance model applied to individuals caring for oncology patients the effect of psychoeducation intervention on balanced life psychological well-being and self-efficacy It will be carried out as a randomised control group experimental research with pretest-posttest follow-up The independent variable of the study is positive psychotherapy balance model based psychoeducation intervention The dependent variables are Balanced Life Scale Psychological Well-Being Scale Self-Efficacy Scale The control variables are the socio-demographic characteristics of the participants gender age educational status marital status etc and the characteristics related to the caregiving process duration of care time allocated for care etc
Hypothesis 1 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of balanced life
H11 Positive psychotherapy balance model based psychoeducation has an effect on increasing the level of success
H12 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of relationship
H13 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of futuremeaningspirituality
H14 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the body level
Hypothesis 2 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of psychological well-being
Hypothesis 3 Positive psychotherapy balance model based psychoeducation has an effect on increasing general self-efficacy level
Research data will be collected with data collection tools after obtaining ethics committee and institutional permission Psychoeducation based on the positive psychotherapy balance model will be carried out face-to-face with caregivers of individuals with colorectal cancer in a city hospital
The population of the study will consist of caregivers of individuals diagnosed with colorectal cancer in a city hospital The sample of the study was calculated by performing power analysis with GPower 3194 programme As a result of the power analysis based on a similar study for the research designed as a control and an intervention group the total sample size was calculated as 38 people in the groups of 19 people at the 85 Power 005 alpha significance level with the prediction that the difference in the medium effect size f025 between the groups in the pre and post evaluations for the two groups would be considered statistically significant Considering the possibility of caregivers dropping out or being excluded from the study it was decided to include 8 additional people 4 in each group A total of 46 caregivers in the intervention and control groups will constitute the sample of the study
Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined via the internet Group 1 Intervention Group Group 2 Control Group Afterwards they will be assigned to the groups in accordance with the order in the randomisation table The randomisation result will be indicated in the form of a table
Personal information form Balanced Life Scale Psychological Well-Being Scale and Self-Efficacy Scale will be used as data collection tools
Data collection tools will be applied to all caregivers who agree to participate in the study and meet the inclusion criteria and a brief information about the psychoeducation process will be given Psychoeducation based on Positive Psychotherapy Balance Model will be conducted in 5 sessions 5 weeks one day a week 90-120 minutes The control group will receive a one-session 60 minutes information training after 3 weeks
After all sessions are completed post-tests will be applied to the intervention group and the control group Follow-up data will be collected from the intervention and control groups 3 months after the psychoeducation programme is completed After the end of the study PPT Balance Model Based Psychoeducation will be given to the caregivers in the control group
Ethics committee and institutional permission will be obtained from Istanbul Prof Dr Cemil Taşcıoğlu City Hospital Interventional Health Sciences Research Ethics Committee for the implementation of the research After the individuals included in the study are informed about the research their written and verbal consent will be obtained through data collection forms
SPSS 150 for Windows programme will be used for statistical analysis
The principle of balance which is one of the principles of positive psychotherapy argues that it is possible for individuals to cope with their conflicts by allocating their life energies to four areas in a balanced way In accordance with the principle of balance individuals should use the areas of body relationship success and futurespirituality in a balanced way in order to solve the problems they experience Because according to positive psychotherapy it is possible for individuals to have a fully healthy and productive life with the importance they will give to these four basic life dimensions and the balanced use of the time and energy they will spend In the context of positive psychotherapy an individual who has a balanced life goal and also has high general self-efficacy skills is expected to be more courageous and willing to show the necessary efforts to maintain a balanced life Because the individual with high general self-efficacy skills will have a strong belief in overcoming the problems heshe may encounter despite the effort heshe will make for a balanced life and thus the individual who has the desire to live a balanced life and can find the competence to make the necessary efforts will be able to keep hisher motivation high to continue hisher efforts as heshe sees the positive changes in hisher life with the steps heshe will take The concept of psychological well-being which focuses on the self-development and growth of the individual by realising hisher own meaning competence and capacity based on the individuals own self-powers and competencies is the natural result of the process experienced by the individual aiming for such a life at this point In this direction it can be said that adopting a loving connected and balanced state of mind in the face of the difficulties experienced by caregivers and the responsibilities they undertake will increase the joy meaning self-sufficiency in life and as a result may contribute positively to their level of well-being All these results help caregivers to recognise their own resources maintain their life balance and adopt a positive perspective towards themselves
Materials and Methods In this study positive psychotherapy balance model applied to individuals caring for oncology patients the effect of psychoeducation intervention on balanced life psychological well-being and self-efficacy It will be carried out as a randomised control group experimental research with pretest-posttest follow-up The independent variable of the study is positive psychotherapy balance model based psychoeducation intervention The dependent variables are Balanced Life Scale Psychological Well-Being Scale Self-Efficacy Scale The control variables are the socio-demographic characteristics of the participants gender age educational status marital status etc and the characteristics related to the caregiving process duration of care time allocated for care etc
Hypothesis 1 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of balanced life
H11 Positive psychotherapy balance model based psychoeducation has an effect on increasing the level of success
H12 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of relationship
H13 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of futuremeaningspirituality
H14 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the body level
Hypothesis 2 Positive psychotherapy balance model-based psychoeducation has an effect on increasing the level of psychological well-being
Hypothesis 3 Positive psychotherapy balance model based psychoeducation has an effect on increasing general self-efficacy level
Research data will be collected with data collection tools after obtaining ethics committee and institutional permission Psychoeducation based on the positive psychotherapy balance model will be carried out face-to-face with caregivers of individuals with colorectal cancer in a city hospital
The population of the study will consist of caregivers of individuals diagnosed with colorectal cancer in a city hospital The sample of the study was calculated by performing power analysis with GPower 3194 programme As a result of the power analysis based on a similar study for the research designed as a control and an intervention group the total sample size was calculated as 38 people in the groups of 19 people at the 85 Power 005 alpha significance level with the prediction that the difference in the medium effect size f025 between the groups in the pre and post evaluations for the two groups would be considered statistically significant Considering the possibility of caregivers dropping out or being excluded from the study it was decided to include 8 additional people 4 in each group A total of 46 caregivers in the intervention and control groups will constitute the sample of the study
Which caregivers will be in the intervention group and which will be in the control group will be determined according to the randomisation table determined via the internet Group 1 Intervention Group Group 2 Control Group Afterwards they will be assigned to the groups in accordance with the order in the randomisation table The randomisation result will be indicated in the form of a table
Personal information form Balanced Life Scale Psychological Well-Being Scale and Self-Efficacy Scale will be used as data collection tools
Data collection tools will be applied to all caregivers who agree to participate in the study and meet the inclusion criteria and a brief information about the psychoeducation process will be given Psychoeducation based on Positive Psychotherapy Balance Model will be conducted in 5 sessions 5 weeks one day a week 90-120 minutes The control group will receive a one-session 60 minutes information training after 3 weeks
After all sessions are completed post-tests will be applied to the intervention group and the control group Follow-up data will be collected from the intervention and control groups 3 months after the psychoeducation programme is completed After the end of the study PPT Balance Model Based Psychoeducation will be given to the caregivers in the control group
Ethics committee and institutional permission will be obtained from Istanbul Prof Dr Cemil Taşcıoğlu City Hospital Interventional Health Sciences Research Ethics Committee for the implementation of the research After the individuals included in the study are informed about the research their written and verbal consent will be obtained through data collection forms
SPSS 150 for Windows programme will be used for statistical analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None