Clinical trial NCT06840301: The Effect of Mindfulness Compassionate Living Training on Ruminative Thinking and Sleep Quality
Official title: The Effect of Mindfulness Compassionate Living Training on Ruminative Thinking and Sleep Quality in Informal Caregivers of Inpatients in Palliative Clinic: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness Compassionate Living Training
Keywords: Mindfulness
Sleep Quality
Ruminative Thinking
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to evaluate the effects of Mindfulness Compassionate Living training on ruminative thinking and sleep quality in informal caregivers of patients in a palliative clinic in Turkey. The data of the study will be conducted between November 2024 and April 2025 in the Palliative Clinic of Atatürk University Health Research and Application Center located in the city center of Erzurum. The universe of the study will consist of individuals between the ages of 18 and 45 who are caregivers of patients in the palliative clinic during the specified date range. The sample size of the study was calculated using the GPower computer program. In the calculation made with the power analysis at α=0.05 level, the effect size was 150, 153 (d=0.8) and the power of the study was 90%, it was calculated that at least 68 patients should be included in the sample. Patients who meet the research criteria and agree to participate in the study will be randomly assigned to one experimental and one control group.An introductory information form prepared by the researcher in line with the literature, containing the socio-demographic data of patients and their caregivers in the palliative clinic, the Ruminative Thinking Style Scale to assess the general thought tendency of individuals, the Level 2 Sleep Disorder Adult Short Form (PROMIS) to assess sleep quality, the Self-Compassion Scale Short Form (SCI-S) to assess self-compassion, and the Mindful Awareness Scale (MMIS) to assess conscious awareness will be used.

Detailed description: Research data will be collected face to face by the researcher. The study will be conducted with informal caregivers who meet the inclusion criteria (being a caregiver of the patient in a palliative clinic, being willing to participate in the research, being open to communication and cooperation). Pre-test measurement tools will be applied to the informal caregivers participating in the study. Then, Mindfulness Compassionate Living Training will be applied. Eight After the session application process, the final test data will be applied.

Eligibility criteria: Inclusion Criteria:

1. Being a caregiver of a patient in a palliative clinic,
2. Being between the ages of 18 and 45,
3. Being willing to participate in the study
4. Being open to communication and cooperation

Exclusion Criteria:

1. Having a psychiatric problem in the caregiver of a patient in a palliative clinic.
2. Not being open to communication and cooperation,

Primary outcomes:
measure: Introductory Information Form
timeFrame: up to 1 day
Secondary outcomes:
measure: Ruminative Thinking Style Scale
timeFrame: up to 1 day
Other outcomes:
measure: Level 2 Adult Sleep Disorder Short Form (PROMIS)
timeFrame: up to 1 day
measure: Self-Compassion Scale Short Form (SCI-K)
timeFrame: up to 1 day
measure: Conscious Awareness Scale (CAS)
timeFrame: up to 1 day
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Nursing
state: Yakutiye
Study officials:
affiliation: Ataturk University Faculty of Medicine
name: Pınar Tosun Taşar (Associate Professor)
role: STUDY_CHAIR
References: