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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05891223
Other study ID # suheylayarali
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 5, 2024
Est. completion date June 20, 2024

Study information

Verified date January 2024
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, aimed to determine the effect of "Mindfulness Based Compassionate Life Training" given to university students on coping with post-earthquake trauma stress and grief process. According to the experimental design with pre-test and post-test control group, the participants selected from the universe will be assigned to the experimental and control groups impartially. In this study, a priori power analysis will be performed to determine the sample size. For the independent groups, in which the effect of "Mindfulness-Based Compassionate Life Training" on coping with post-earthquake trauma stress and grief will be compared, 80% power will be achieved at a significance level of 0.05 at a 95% confidence interval. A total of 68 participants will be reached by taking into account data losses and including 30% backup sample in the research. Participants included in the study will be numbered from 1 to 68 and 34 experimental and 34 control groups will be created from www.random.org. Pre-test data will be collected before applying to earthquake survivors in the experimental group and control group. 8 sessions of Mindfulness Based Compassionate Life training will be given to earthquake survivors in the experimental group. Training sessions will be held online. For its effectiveness and continuity, each session will be held between 3 days and 7 days. One week after the Mindfulness-Based Compassionate Living training (after 8 sessions were completed), the "Post-earthquake Trauma Stress Level Determination Scale (NSSTDBÖ)", "The Grief Scale" was administered to the earthquake survivors. The "Self-Compassion Scale Short Form (STS-F)" post-test will be filled in by face-to-face interview. Post-test data from the experimental and control groups will be obtained simultaneously.


Description:

Research data will be collected face to face by researchers. 68 earthquake survivors who meet the inclusion criteria (to be studying at a university, to be affected by the earthquake, to be willing to participate in the study, to be open to communication and cooperation) will be included in the study. The descriptive features form consisting of 8 questions for data collection, "Post-earthquake Trauma Stress Level Detection Scale", "Mourning Scale". "Self-Compassion Scale Short Form (STS-F)" will be used. Research data will be collected as a pre-test and post-test for 1 month. Those who do not regularly participate in the Mindfulness-Based Compassionate Living training will be excluded from the study. The research will be carried out with 68 participants, 34 in the experimental group and 34 in the control group.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 68
Est. completion date June 20, 2024
Est. primary completion date June 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having a university nursing education - Being affected by the earthquake - Willingness to participate in the study - Being open to communication and cooperation Exclusion Criteria: - Not attending sessions regularly

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
The practice of "Breath break with kindness" will be applied for 5 minutes. Afterwards, 15 minutes of information on threats, impulses and soothing systems, "A safe place" application for 11 minutes, "Courtesy meditation" for 10 minutes. After each application, 10 minutes of feedback will be received from the participants.
Session 2: Threat and Self-Compassion
The practice of "breathing with kindness" will be done for 7 minutes. The practice of "Building a compassionate relationship with resilience" will be held for 12 minutes, and the practice of "Kindness meditation: a benevolent" will take place for 11 minutes. "A hand over your heart" application will be made for 3 minutes and "A compassionate comrade" application will be done for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
Session 3: Unraveling the Knots of Desire and Patterns
The practice of "breathing with kindness" will be done for 7 minutes. "Building a compassionate relationship with desire" 12 minutes, "Guided meditation to discover the inner pattern" 10 minutes and "Courtesy meditation: a good friend" 11 minutes. Except for the "breath break with kindness" application, 3 minutes of feedback will be received from the participants after each application.
Session 4: Internalizing compassion
The "pretend-to-be" practice for the participants to observe themselves will be made for 10 minutes. The practice of "internalizing compassion" will be done for 7 minutes, "kindness meditation: a neutral person" practice for 10 minutes, and "kindness towards your body" for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
Session 5: Me and others - Expanding the circle
The "a compassionate letter" practice with the participants will continue for 15 minutes. "Courtesy meditation: the 'difficult' person" 8 minutes, "compassion and breathing: yourself" 10 minutes and "compassionate breathing: others" 7 minutes. A "compassionate break" application is performed for 7 minutes.
Session 6: Growing happiness
The practice of "Revisiting the good" is carried out for 10 minutes with the participants. "Forgive yourself", "wish for forgiveness", "forgive others", "gratitude" practices will be held for 5 minutes each and will take 20 minutes in total. "Courtesy meditation: groups and all beings" will be practiced for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
Session 7: Weaving Wisdom and Compassion into Daily Life
Participants will be given 10 minutes to choose a day in their life and allow a few minutes to pause mindfully. The practice of "a breather for wise and compassionate action" is 10 minutes, the practice of "calmness meditation" is 8 minutes, and the practice of "sharing the joy meditation" is 8 minutes. After each application, 3 minutes of feedback will be received from the participants.
Session 8: Living with the Heart
The participants are told about the applications they can apply for, where they need help to develop compassion towards self-healing skills, and the entire training will be evaluated for 20 minutes. The "river of life" application is carried out for 20 minutes. 10 minutes of feedback will be received after the application.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Outcome

Type Measure Description Time frame Safety issue
Other Grief Scale The grief scale developed by Balci (2006) measures the physical, emotional, intellectual and behavioral changes that occur in the individual after the loss of a loved one or persons. The scale consists of 35 items and four sub-dimensions. Items 11, 13 and 17 are reverse coded. Individuals are given statements about the situations they may experience in the face of a separation or loss, on a scale of 1-5, (5) Always, (4) Often, (3) Occasionally, (2) Rarely, (1) They are asked to rank as Never. The highest score that can be obtained from the entire scale is 175, and the lowest score is 35. The scale has no cut-off point. It is stated that the higher the score, the higher the level of grief. The Cronbach Alpha internal consistency coefficient for the internal consistency reliability of the scale is .96. [Time Frame: up to 5 week ]
Other Short Form of Self-Compassion Scale (SSS-C) The Turkish validity and reliability of the scale developed by Neff (2003) was made by Yildirim and Sari in 2018. The scale was confirmed to have a structure consisting of 11 items, a single dimension, and two complementary components (positive component and negative component). The internal consistency coefficient of the scale was calculated as .75. SSS-F Total score is used to measure self-compassion. It is stated that as the score increases, the level of Self-compassion increases. This scale was used by Liu et al. was used as a measurement tool in the evaluation of individuals who experienced earthquakes. (Liu., et all, 2021) [Time Frame: up to 5 week ]
Primary Introductory Information Form The form consists of 8 questions containing information about the students affected by the earthquake created by the researcher within the scope of the literature. The form created, gender, place of residence, the state of being together with the parents, whether the parents are alive or not, the place where they stayed during the earthquake (home, dormitory, etc.) to what extent they were affected by the earthquake, the status of losing a relative in the earthquake, the status of receiving psychological support after the earthquake, more It includes questions about experiencing a traumatic event before and having a previously diagnosed psychiatric illness. [Time Frame: up to 1 day]
Secondary Post-earthquake Trauma Stress Level Scale (DSSTDBÖ) DSTDBĂ– is a tool developed by Tanhan and Kayri (2013) to measure the stress levels experienced by individuals after an earthquake. The scale consists of 20 items. The scale was arranged with a 5-point Likert-type rating of "strongly disagree", "little agree", "moderately agree", "strongly agree".
and "totally agree" format. The lowest score that can be obtained from the scale is 20 and the highest score is 100. The increase in the scores obtained from the scale shows that the individuals' level of being affected by the earthquake also increases. The internal consistency coefficient (Cronbach's alpha) of the DSDTDS was found to be .87.
[Time Frame: up to 5 week ]
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