- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05310656
Evaluation of the Impact of the Empowerment Program on Sheltered Battered Women (Violence)
The Effect of Mindfulness Based Empowerment Program on Self-Compassion, Self-Esteem and Ways of Coping With Stress of Women Experienced Violence: A Randomized-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
When the statistics on violence against women in the world are analyzed, it is seen that 16-25% of women are physically abused by their husbands, boyfriends or fiancees, and one out of every five women is exposed to this type of violence in their own home. It has been concluded that the approaches applied in intervention studies for women exposed to violence affect women's mental health positively, increase their self-esteem, improve their coping, problem-solving and decision-making skills, reduce their anger and stress levels, and increase their self-efficacy. In addition, it has been determined that mindfulness-based interventions applied to women who have been subjected to violence strengthen awareness and self-compassion, improve sense of belonging, compassion and problem-solving skills, reduce self-blame, depression, anxiety and suicidal thoughts, increase psychological well-being, and reduce PTSD symptoms. With the continuation of exposure to violence, women are insufficient to change their feelings and lives in a positive way, they are affected by the negative and judgmental attitudes of their environment, they struggle with all the negative effects of violence throughout their lives, they experience physical and mental disorders due to violence, and therefore they resort to harmful coping methods. In this sense, the aim of the study is to determine the effect of mindfulness-based empowerment program on self-compassion, self-esteem and ways of coping with stress in women exposed to violence.
The hypotheses of this study:
In the mindfulness-based empowerment program applied to women who have been subjected to violence, H0-1: There is no difference between the intervention group and the control group in terms of self-compassion.
H0-2: There is no difference between the intervention group and the control group in terms of self-esteem.
H0-3: There is no difference between the intervention group and the control group in terms of coping styles with stress.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Güzide Emirza, Res. Asist.
- Phone Number: +905433320212
- Email: guzzide@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women who have been exposed to at least one of the types of violence,
- Women who can read, write and understand Turkish will be included in the study.
Exclusion Criteria:
- Women with severe mental retardation,
- Women with psychotic symptoms and impaired ability to assess reality,
- Women who do not have insight due to psychiatric disorder,
- Women whose cognitive functionality is impaired,
- Women with any physical limitations will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Mindfulness-based empowerment programme
|
Mindfulness Based Strengthening Program consists of 8 sessions, once a week.
Each session has specific goals and objectives, and each session also has a separate theme along with its subject.
The subject of the program sessions is as follows: 1st session; Getting to know, explaining the operation plan of the program, defining violence against women and its causes, 2nd session; Emotions and Perceptions, session 3; Being in the Body and Developing Self-Esteem; Session 4, Stress and Meeting Stress with Conscious Awareness; Session 5, The Case of Violence and the Meanings We Ascribe; Session 6, Aware Communication and Conflict Resolution; Session 7, Self-Care and Self-Compassion; Session 8 is Ending the Empowerment Program, Farewell, and a New Beginning.
Each session is planned to last an average of 90-120 minutes.
Mindfulness teachings and practices will be applied in the content of the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Esteem
Time Frame: 8 weeks after enrollment
|
Coopersmith Self-Esteem Scale: Coopersmith (1967) found the reliability coefficient of the scale to be 0.91 for women and 0.80 for men.
In addition, the Cronbach's alpha coefficient of the scale was determined as 0.86.
Each item of the scale, which consists of 25 items, is determined according to two options as "suitable for me" and "not suitable for me".
Scoring of the scale is made as "4" for each correct statement, "0" for each incorrect statement, the highest score that can be obtained from the scale is 100, and the lowest score is 0. As the score obtained from the scale increases, the self-esteem of individuals also increases.
In the scale, a self-esteem level below 50 points is considered low, and a self-esteem level above 50 points is considered high.
There is no reverse coded item in the scale.
|
8 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ways of Coping with Stress
Time Frame: 8 weeks after enrollment
|
Styles of Coping with Stress Scale: The scale consists of 30 items in total.
The scale is a 4-point Likert type measurement tool.
Options are rated as "Not at all suitable", "Not very suitable", "Appropriate" and "Totally appropriate".
In the evaluation of the scale, the total score cannot be obtained, and the scores are calculated separately for each subscale.
The answers given to each item are scored as 0,1,2,3, and the scores of each individual in each subgroup are summed up one by one and divided by the number of items in that group.
Thus, the average score of each subgroup is obtained.
However, items 1 and 9 in the Seeking Social Support group are reverse scored.
The increase in the scores obtained from each subscale indicates that the approach of that scale is used more strongly.
|
8 weeks after enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion
Time Frame: 8 weeks after enrollment
|
Self-Compassion Scale: The scale is a measurement tool that evaluates the characteristics associated with the sub-dimensions of self-compassion and is based on the individual giving information about himself (self-report).
The Self-Compassion Scale has a 5-point Likert-type rating: (1) never (2) rarely (3) often (4) often and (5) always.
The scale consists of 26 items.
In the confirmatory factor analysis, the existence of 6 sub-dimensions constituting the self-compassion structure was confirmed.
|
8 weeks after enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elif Güzide Emirza, Res. Asist., Gazi University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EGUAY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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