An interventional study of Mindfulness-based breathing therapy program in Palliative Supportive Care and Care Giving Burden, sponsored by Istanbul Aydın University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by Istanbul Aydın University · Not applicable, Interventional, and Supportive care
Aims and objectives: The aim of this study was to assess the effects of mindfulness-based breathing therapy on the levels of perceived stress, caregiver burden and burnout in caregivers of palliative care patients.
Background: It is extremely important to develop evidence-based strategies to protect the psychological health of caregivers, who are part of palliative care, to increase their quality of life and to facilitate their adaptation to the palliative care process.
Design: This was a prospective, single-blind, randomised controlled study. The study complied with the guidelines of Consolidated Standards of Reporting Trials (CONSORT).
Methods: A total of 100 caregivers were randomly assigned to intervention group (n = 50) and control group (n = 50). This single-blinded randomized controlled trial was conducted at the palliative care unit of a private hospital, between May-November 2021. Personal information form, caregiver strain index (CSI), Zarit burden interview (ZBI) and Maslach Burnout Inventory (MBI) were used for data collection.
3.4. Procedures Participant caregivers of palliative patients were randomized into the intervention and the control groups. Prior to randomization, participants and nurses were informed online abut the aim of the research and their written consent was obtained. Once the study ended, mindfulness-based breathing therapy were recommended to the patients in the control group. Data were collected online via Google forms survey and the interviews were conducted online via Zoom. The Principal Investigator, study statisticians, and study staff, who took part in collecting outcome assessments, were blinded to intervention condition. All the measurement scores were obtained by another researcher nurse blinded to arm allocation.
3.4.1. Control Group Participants in the control group were asked to complete the personal information form, CSI, ZBI and MBI online, and sit in a relaxed position in a quiet environment for 30 minutes for three consecutive days. They completed the CSI, ZBI and MBI as posttest at the end of the third day.
3.4.2. Intervention Group 50 participants in the intervention group were divided into ten groups with five participants in each group. After completing the personal information form online, a meeting time was set for each of the ten groups. Participants were asked to be in a quite environment during the meeting and complete the CSI, ZBI and MBI as pretest via Google forms survey. Each group received mindfulness-based breathing therapy for 30 minutes in three consecutive sessions from an expert on the therapy. At the end of the third session, participants completed the CSI, ZBI and MBI as posttest.
Mindfulness-based breathing therapy sessions started by informing the participants about the content of each session and the relaxation effects of breathing on mind and body to cope with stress. Before the breathing exercise, participants were asked to sit in a relaxed position, loosen buttons and belts, take out shoes and close their eyes. They were suggested to put self-judgment aside, focus on the present moment, their breath and finally on each part of their body. To develop concentration and mental flexibility about their bodies, participants were asked to focus on their bodies in a comprehensive and transient way. They were asked to focus on each part of their body stage by stage, combine their consciousness about their breath and body and feel the breath at each part of their body. During the breathing exercises, participants were asked to focus on, feel and realize their emotions. 'TV screen metaphor' was used to put a distance to their opinions and thoughts. They were asked to think about a situation, which made them anxious and stressful, reflect their experience onto a TV screen and think as if they were watching their experience on TV. A piano song was played as background music during the sessions. After taking deep breath for three times, participants were asked to open their eyes.
439 studies on the registry are indexed under Caregiver Burden; 154 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 346 interventional studies indexed under Caregiver Burden.
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Other: Mindfulness-based breathing therapy program
Participant caregivers of palliative patients were randomized into the intervention and the control groups. Prior to randomization, participants and nurses were informed online abut the aim of the research and their written consent was obtained. Once the study ended, mindfulness-based breathing therapy were recommended to the patients in the control group. Data were collected online via Google forms survey and the interviews were conducted online via Zoom.
Personal Information Form
The form was developed by the researchers in line with the literature and included questions on sociodemographic characteristics of the participants, such as age, gender and education level
Time frame: Baseline
Caregiver Strain Index
CSI was developed by Robinson (1983) to measure the burden of care on caregivers and was adapted to Turkish by Uğur \& Fadıloğlu (2010). The scale had 13 items, which were scored on a two-point Likert scale, ranging from yes (1 point) to no (0 point).
Time frame: Baseline
Caregiver Strain Index
CSI was developed by Robinson (1983) to measure the burden of care on caregivers and was adapted to Turkish by Uğur \& Fadıloğlu (2010). The scale had 13 items, which were scored on a two-point Likert scale, ranging from yes (1 point) to no (0 point).
Time frame: on the seventh day
Zarit Burden Interview
The scale was developed by Zarit et al (1980) and was adapted to Turkish by İnci and Erdem (2008). The scale included 22 items about the impact of caregiving on the life of caregiver, including the psychological and health status and the social life of the caregiver, economic burden on caregiver and the patient/caregiver relationship. Items were scored on a five-point Likert scale, ranging from 0 (never) to 4 (always)
Time frame: baseline
Zarit Burden Interview
The scale was developed by Zarit et al (1980) and was adapted to Turkish by İnci and Erdem (2008). The scale included 22 items about the impact of caregiving on the life of caregiver, including the psychological and health status and the social life of the caregiver, economic burden on caregiver and the patient/caregiver relationship. Items were scored on a five-point Likert scale, ranging from 0 (never) to 4 (always)
Time frame: on the seventh day
Maslach Burnout Inventory (MBI)
The Scale was developed by Maslach and Jackson (1981) and was adapted to Turkish by Çapri (2006). The scale was composed of 22 items in three subscales, including emotional exhaustion (items 1, 2, 3, 6, 8, 13, 16 and 20), depersonalization (items 5, 10, 11, 15 and 22) and personal accomplishment (items 4, 7, 9, 12, 17, 18, 19 and 21). Emotional exhaustion and depersonalization subscales had items with negative statements whereas the items in the personal accomplishment subscale were positive
Time frame: baseline
Maslach Burnout Inventory (MBI)
The Scale was developed by Maslach and Jackson (1981) and was adapted to Turkish by Çapri (2006). The scale was composed of 22 items in three subscales, including emotional exhaustion (items 1, 2, 3, 6, 8, 13, 16 and 20), depersonalization (items 5, 10, 11, 15 and 22) and personal accomplishment (items 4, 7, 9, 12, 17, 18, 19 and 21). Emotional exhaustion and depersonalization subscales had items with negative statements whereas the items in the personal accomplishment subscale were positive
Time frame: on the seventh day
Plan to share: No
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Istanbul Aydın University