Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05187130
Status:
COMPLETED
Last Update Posted:
2023-05-25
First Post:
2021-12-24
Brief Title:
The Effect of Mindfulnes Program on Stress Depression and Psychological Well-being in Cancer Patients
Sponsor:
Istanbul Aydın University
Organization:
Istanbul Aydın University
Study Overview
Official Title:
The Effect of Mindfulnes Program on Stress Depression and Psychological Well-being in Cancer Patients Single Blinded Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Study design A single blinded randomized controlled experimental design was used The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials CONSORT checklist
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in IstanbulTurkey
Inclusion criteria Patients aged 18 and over volunteering to participate in the study conscious and without communication problems who did not take any course or practice intervention on anxiety tension depression symptoms and coping with stress were included in the study Participitants randomised intervention and controlled groups
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in IstanbulTurkey
Inclusion criteria Patients aged 18 and over volunteering to participate in the study conscious and without communication problems who did not take any course or practice intervention on anxiety tension depression symptoms and coping with stress were included in the study Participitants randomised intervention and controlled groups
Detailed Description:
Study design A single blinded randomized controlled experimental design was used The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials CONSORT checklist
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in IstanbulTurkey
Inclusion criteria Patients aged 18 and over volunteering to participate in the study conscious and without communication problems who did not take any course or intervention on anxiety tension depression symptoms and coping with stress were included in the study
Sample size and randomization The sample number was calculated using the GPower 319 version program At an effect size of 05 and an error level of 005 alpha the required sample size was determined to be at least 54 individuals for each group A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature Lee et al 2020 The power of the analysis made with this sample size was determined as 931 Considering the losses during the study the sample number for each group was determined as 60 people
The groups of participants who agreed to participate in the study were determined by the program with the randomization URL httpwwwrandomizationcom In order to distribute the numbers to the groups the numbers from 1 to 120 were randomly assigned to the two groups assuming that set 1 would represent the intervention group and set 2 would represent the control group In line with the program the order of the patients forming the sample group was determined by randomization A total of 130 patients 65 in the intervention group and 65 in the control group were included in the study 5 participants in the intervention group who did not want to participate and died during the study and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation In the study the results of a total of 120 patients 60 in the intervention group and 60 in the control group were analyzed
MeasuresInstruments Participant Information Form State Anxiety Inventory Beck Depression Inventory and Psychological Well-Being Scale were used to collect research data Survey Monkey was used as the data collection method The Survey Monkey survey was created which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses
Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in IstanbulTurkey
Inclusion criteria Patients aged 18 and over volunteering to participate in the study conscious and without communication problems who did not take any course or intervention on anxiety tension depression symptoms and coping with stress were included in the study
Sample size and randomization The sample number was calculated using the GPower 319 version program At an effect size of 05 and an error level of 005 alpha the required sample size was determined to be at least 54 individuals for each group A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature Lee et al 2020 The power of the analysis made with this sample size was determined as 931 Considering the losses during the study the sample number for each group was determined as 60 people
The groups of participants who agreed to participate in the study were determined by the program with the randomization URL httpwwwrandomizationcom In order to distribute the numbers to the groups the numbers from 1 to 120 were randomly assigned to the two groups assuming that set 1 would represent the intervention group and set 2 would represent the control group In line with the program the order of the patients forming the sample group was determined by randomization A total of 130 patients 65 in the intervention group and 65 in the control group were included in the study 5 participants in the intervention group who did not want to participate and died during the study and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation In the study the results of a total of 120 patients 60 in the intervention group and 60 in the control group were analyzed
MeasuresInstruments Participant Information Form State Anxiety Inventory Beck Depression Inventory and Psychological Well-Being Scale were used to collect research data Survey Monkey was used as the data collection method The Survey Monkey survey was created which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses
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