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Completed

NCT Number: NCT05187754

The Effects of Mindfulness-based Breathing Therapy

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.

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Key information

Conditions

Palliative Supportive Care Behavior Behavioral Symptoms Burnout, Psychological Care Giving Burden Caregiver Burden Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary caregivers of palliative patients,
  • who were 18 years of age and above,
  • Did not have any visual or auditory disabilities, were included to the study

Exclusion criteria

  • Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression)
  • Take another psychological relaxation course or training

Treatment and study plan

Mindfulness-based breathing therapy program

Other

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.

Primary outcomes

  1. Personal Information Form

    Time frame: Baseline

    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

  2. Caregiver Strain Index

    Time frame: Baseline

    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).

  3. Caregiver Strain Index

    Time frame: on the seventh day

    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).

  4. Zarit Burden Interview

    Time frame: baseline

    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)

  5. Zarit Burden Interview

    Time frame: on the seventh day

    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)

  6. Maslach Burnout Inventory (MBI)

    Time frame: baseline

    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

  7. Maslach Burnout Inventory (MBI)

    Time frame: on the seventh day

    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

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

The Effects of Mindfulness-based Breathing Therapy on Perceived Stress, Caregiver Burden and Burnout in Caregivers of Palliative Care Patients: Single-blind, Randomised Controlled Study.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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