NCT05310656

Brief Summary

This study aims to increase the level of self-compassion, improve their self-esteem and cope with stress so that women who are exposed to violence can fight violence more effectively, protect their physical and mental health, find the strength they need to direct their lives, and do all these through self-awareness, compassion and kindness. It is aimed to gain coping skills. For this purpose, a mindfulness-based strengthening program will be implemented.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

March 4, 2022

Last Update Submit

April 4, 2022

Conditions

Keywords

womenviolencemindfulnessempowerment programmeself-compassion

Outcome Measures

Primary Outcomes (1)

  • Self-Esteem

    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 Outcomes (1)

  • Ways of Coping with Stress

    8 weeks after enrollment

Other Outcomes (1)

  • Self-Compassion

    8 weeks after enrollment

Study Arms (1)

Mindfulness-based empowerment programme

EXPERIMENTAL
Behavioral: Mindfulness Based Empowerment Programme

Interventions

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.

Mindfulness-based empowerment programme

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe program to be implemented for women who have been subjected to violence aims to strengthen the individual and social empowerment of women who are isolated due to the violence and oppression they are exposed to. Due to violence against women in society, many women have been oppressed and their empowerment has been hindered. For this reason, women who have been traumatized, excluded and subjected to violence are included in the study.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Emirza EG, Bilgili N. The Effect of Mindfulness-Based Empowerment Program on Self-Compassion, Self-Esteem and Ways of Coping With Stress of Women Experienced Violence: A Randomised Controlled Study. Int J Ment Health Nurs. 2024 Dec;33(6):2314-2325. doi: 10.1111/inm.13401. Epub 2024 Aug 12.

Study Officials

  • Elif Güzide Emirza, Res. Asist.

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Güzide Emirza, Res. Asist.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Due to the nature of the research, it is not possible to blind the researcher and the participant because the researcher applied the mindfulness-based empowerment program, took part in the data collection and analysis phase, and the women in the intervention group were aware of the practice.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The universe of the research will be the women who have been subjected to violence staying in women's shelters in a province in Turkey. Women who volunteer to participate in the study will be included in the study. As a result of the power analysis using the G\*Power 3.1 program; With 95% power, 5% margin of error and d=0.84 effect size, a total of at least 42 samples was found to be sufficient (n₁=21; n₂=21). However, considering that losses may also occur, it was planned to work with a total of 60 women, 30 of whom were interventions and 30 were controls. Women who meet the inclusion criteria will be randomly assigned to the intervention and control groups, and at the same time, stratified block randomization will be performed (n₁= 30; n₂=30). The number of people in the group was determined as 10 for reasons such as keeping individuals active, increasing interactive working time, and providing more sharing opportunities.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 4, 2022

First Posted

April 5, 2022

Study Start

May 1, 2022

Primary Completion

July 18, 2022

Study Completion

August 18, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

It is planned to share the study protocol, data analysis, informed consent form and clinical study report of the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
March 2022-December 2022