Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05601024
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2022-10-26
Brief Title:
The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With StomaRandomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Stoma is a surgical intervention to ensure that body wastes are removed differently from the normal physiological opening The stoma patient has to cope with complex emotional social and physical problems associated with this change Physical health problems such as stoma change in body image and negative emotions affect self-esteem and quality of life Laughing provides mental and physical relaxation with the release of endorphins Therefore laughter therapy has an important contribution to increase the well-being of patientsThis study was planned as a randomized controlled experimental study to evaluate the effect of laughter therapy on self-esteem and quality of life in patients with stoma
Detailed Description:
The total number of individuals with a stoma is thought to be between 725000 and 1 million Faqs 2020 Stoma can cause many physical social cognitive and emotional problems in an individuals life These problems can negatively affect the quality of life of patients with stoma Karadag et al 2011
Self-esteem is an individuals positive or negative evaluation of himselfherself Ayaz 2008 This evaluation stems not from the individuals need to feel perfect but from the need to accept himself and be accepted by others Physical health problems changes in body image and negative emotions affect self-esteem
Laughter is generally considered to be a visual expression of happiness or a feeling of joy and it occurs with stimuli such as hearing a joke or being tickled Neurophysiology has shown that laughter is associated with the activation of the lower middle frontal lobe cortex which produces endorphins Satish 2012 Laughing provides mental and physical relaxation with the release of endorphins Farifteh et al 2014
Psychological benefits of laughing
Decreases symptoms of depression anxiety and stress level
Increases self-confidence hope energy and strength
Increases memory creative thinking and problem solving ability
Increases interpersonal relationship and social interaction
Collaboration enhances group identity and solidarity
Strengthens the relationship between the health personnel and the patient
Provides psychological well-being
Increases joy and its mostly contagious Ripoll and Casado 2010
It was found to increase optimism and self-esteem in a study of menopausal women Cha et al 2013 As a result of Cho and Ohs 2011 study it was stated that laughter therapy can be an effective nursing intervention applied to increase the quality of life and recovery in individuals with breast cancer Although laughing therapy was applied in different patient groups and its positive effects were proven a study on patients who had undergone surgical intervention could not be reached This study was planned as a randomized controlled experimental study to evaluate the effect of laughter therapy on self-esteem and quality of life in patients with stoma
Study Population and Sampling In the study in calculating the sample size to be used to measure the effect of laughter therapy on self-esteem and quality of life in patients with stoma the d value was determined as d 066 α 005 margin of error 1-β 095 power in the light of academic studies With the help of the G-power version 31 package program the number of samples to be included in the study was calculated as 68 people Yoshikawa et al 2019 Considering a possible 10 loss in the study it was decided to include a total of 74 participants 37 participants in each group
Randomization The research was conducted as an open-label blinded randomized and controlled experimental study A simple computer-assisted randomization method was used to distribute the groups homogeneously
For this purpose 74 sets were created using the functions available on the httpswwwrandomorginteger-sets website In each of these sets there were a total of 8 participants 4 participants from the experimental group and 4 participants from the control group The 74 sets created as the next process were shown with 1 number each RANDBETWEEN function was used in Excel Thus 10 numbers between 1 and 74 were generated and 10 sets to be used in randomization were randomly determined 72 patients were randomized in the first 9 sets and 2 patients in the 10th set
Data Collection Method Data will be collected by the researcher by calling the participants by phone WhatsApp video chat method will be applied for the individuals in the experimental group
Data Collection Tools
1 Personal information form sociodemographic characteristics With this form which was prepared by the researcher in line with the literature it is planned to obtain information about the sociodemographic characteristics gender age occupation etc and stoma diagnosis stoma type etc of the participants
2 Rosenberg Self-Esteem Scale Rosenberg Self-Esteem Scale was developed by Morris Rosenberg in 1965 In 1985 The validity and reliability study of the scale which was translated into Turkish by Dr Füsun Çetin Çuhadaroğlu was also conducted by Çuhadaroğlu Çuhadaroğlu 1986 This scale consists of 10 questions that measure self-esteem IThe highest score that can be obtained from the scale is 6
3 City of Hope Quality of Life Ostomy The scale was developed by the Hope Center Pain and Palliative Care Research Center in 1995 to evaluate the quality of life of cancer patients It is a 43-item Likert-type scale revised for individuals with ostomy The Turkish adaptation and validity-reliability study of the scale was carried out by Erol and Vural 2012
Intervention
The first component of intervention is the laughter therapy that is a combination of warm up exercise deep breathing exercises childlike playfulness and laughter exercises
Hand clapping and warm-up exercises Hands are kept parallel to each other and clapped so that the fingertips touch each other In order to synchronize the group and increase the energy level of the group rhythms such as ho-ho ha-ha-ha are usually added to the clapping
Deep breathing exercises Deep breathing exercises are exercises for filling and emptying the lungs providing physical and mental relaxation It is applied by breathing through the nose and exhaling slowly through the mouth
Childlike acting One of the purposes of the laughing exercises is that childlike acting comes to life in the mind and helps to laugh During this exercise songs can be sung games can be played and laughing can be helped with music
Laughter exercises yogic laugh exercises Lion laugh cheerful laugh exercises milkshake hot soup laugh and physical laughter exercises
Participants will do laughter therapy with whatsapp group call It is important for participants to share their images and voices in order to make eye contact and hear the sounds of laughter Each group will consist of at least 5 people Each session of laughter therapy will be offered one a weekly and 30-40 minutes each time
Experimental Group
After obtaining permission from the participants patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale sociodemographic characteristics City of Hope Quality of Life Ostomy
Participants in this group will receive a 4 week of laughter therapy Laughter therapy will be conducted on whatsapp
After laughter therapy after 1 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
After 3 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
Control Group
After obtaining permission from the participants patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale sociodemographic characteristics City of Hope Quality of Life Ostomy
After 2 weeks Patients will be called by phone and asked if they have any complaints about their disease
After 1 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
After 3 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
Self-esteem is an individuals positive or negative evaluation of himselfherself Ayaz 2008 This evaluation stems not from the individuals need to feel perfect but from the need to accept himself and be accepted by others Physical health problems changes in body image and negative emotions affect self-esteem
Laughter is generally considered to be a visual expression of happiness or a feeling of joy and it occurs with stimuli such as hearing a joke or being tickled Neurophysiology has shown that laughter is associated with the activation of the lower middle frontal lobe cortex which produces endorphins Satish 2012 Laughing provides mental and physical relaxation with the release of endorphins Farifteh et al 2014
Psychological benefits of laughing
Decreases symptoms of depression anxiety and stress level
Increases self-confidence hope energy and strength
Increases memory creative thinking and problem solving ability
Increases interpersonal relationship and social interaction
Collaboration enhances group identity and solidarity
Strengthens the relationship between the health personnel and the patient
Provides psychological well-being
Increases joy and its mostly contagious Ripoll and Casado 2010
It was found to increase optimism and self-esteem in a study of menopausal women Cha et al 2013 As a result of Cho and Ohs 2011 study it was stated that laughter therapy can be an effective nursing intervention applied to increase the quality of life and recovery in individuals with breast cancer Although laughing therapy was applied in different patient groups and its positive effects were proven a study on patients who had undergone surgical intervention could not be reached This study was planned as a randomized controlled experimental study to evaluate the effect of laughter therapy on self-esteem and quality of life in patients with stoma
Study Population and Sampling In the study in calculating the sample size to be used to measure the effect of laughter therapy on self-esteem and quality of life in patients with stoma the d value was determined as d 066 α 005 margin of error 1-β 095 power in the light of academic studies With the help of the G-power version 31 package program the number of samples to be included in the study was calculated as 68 people Yoshikawa et al 2019 Considering a possible 10 loss in the study it was decided to include a total of 74 participants 37 participants in each group
Randomization The research was conducted as an open-label blinded randomized and controlled experimental study A simple computer-assisted randomization method was used to distribute the groups homogeneously
For this purpose 74 sets were created using the functions available on the httpswwwrandomorginteger-sets website In each of these sets there were a total of 8 participants 4 participants from the experimental group and 4 participants from the control group The 74 sets created as the next process were shown with 1 number each RANDBETWEEN function was used in Excel Thus 10 numbers between 1 and 74 were generated and 10 sets to be used in randomization were randomly determined 72 patients were randomized in the first 9 sets and 2 patients in the 10th set
Data Collection Method Data will be collected by the researcher by calling the participants by phone WhatsApp video chat method will be applied for the individuals in the experimental group
Data Collection Tools
1 Personal information form sociodemographic characteristics With this form which was prepared by the researcher in line with the literature it is planned to obtain information about the sociodemographic characteristics gender age occupation etc and stoma diagnosis stoma type etc of the participants
2 Rosenberg Self-Esteem Scale Rosenberg Self-Esteem Scale was developed by Morris Rosenberg in 1965 In 1985 The validity and reliability study of the scale which was translated into Turkish by Dr Füsun Çetin Çuhadaroğlu was also conducted by Çuhadaroğlu Çuhadaroğlu 1986 This scale consists of 10 questions that measure self-esteem IThe highest score that can be obtained from the scale is 6
3 City of Hope Quality of Life Ostomy The scale was developed by the Hope Center Pain and Palliative Care Research Center in 1995 to evaluate the quality of life of cancer patients It is a 43-item Likert-type scale revised for individuals with ostomy The Turkish adaptation and validity-reliability study of the scale was carried out by Erol and Vural 2012
Intervention
The first component of intervention is the laughter therapy that is a combination of warm up exercise deep breathing exercises childlike playfulness and laughter exercises
Hand clapping and warm-up exercises Hands are kept parallel to each other and clapped so that the fingertips touch each other In order to synchronize the group and increase the energy level of the group rhythms such as ho-ho ha-ha-ha are usually added to the clapping
Deep breathing exercises Deep breathing exercises are exercises for filling and emptying the lungs providing physical and mental relaxation It is applied by breathing through the nose and exhaling slowly through the mouth
Childlike acting One of the purposes of the laughing exercises is that childlike acting comes to life in the mind and helps to laugh During this exercise songs can be sung games can be played and laughing can be helped with music
Laughter exercises yogic laugh exercises Lion laugh cheerful laugh exercises milkshake hot soup laugh and physical laughter exercises
Participants will do laughter therapy with whatsapp group call It is important for participants to share their images and voices in order to make eye contact and hear the sounds of laughter Each group will consist of at least 5 people Each session of laughter therapy will be offered one a weekly and 30-40 minutes each time
Experimental Group
After obtaining permission from the participants patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale sociodemographic characteristics City of Hope Quality of Life Ostomy
Participants in this group will receive a 4 week of laughter therapy Laughter therapy will be conducted on whatsapp
After laughter therapy after 1 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
After 3 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
Control Group
After obtaining permission from the participants patients will be called by phone and questions will be asked about Rosenberg Self-Esteem Scale sociodemographic characteristics City of Hope Quality of Life Ostomy
After 2 weeks Patients will be called by phone and asked if they have any complaints about their disease
After 1 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
After 3 month Patients will be called again by phone to ask questions about the Rosenberg Self-Esteem Scale and City of Hope Quality of Life Ostomy
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