Palliative Supportive CareNCT05187754
The Effects of Mindfulness-based Breathing Therapy
A study testing Mindfulness-based breathing therapy program in people with Palliative Supportive Care and Care Giving Burden, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Supportive Care, Care Giving Burden
- What is being tested?
- Mindfulness-based breathing therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression)
- Take another psychological relaxation course or training
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Palliative Supportive Care, Care Giving Burden
- Being tested
- Mindfulness-based breathing therapy program
- Keywords
- Care Giving Burden, Palliative Supportive Care, Burnout
- Medical subject headings
- Caregiver Burden, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based breathing therapy programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Mindfulness-based breathing therapy program |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: on the seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start30 May 2021
- Primary completion30 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative Supportive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187754
- Sponsor's protocol ID
- Caregiver mindfulnes
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05187754
- Acronym / sponsor ID
- Caregiver mindfulnes
- Conditions
- Palliative Supportive Care, Care Giving Burden
- Keywords
- Care Giving Burden, Palliative Supportive Care, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mindfulness-based breathing therapy program |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression)
- Take another psychological relaxation course or training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based breathing therapy programParticipant 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. | Other | Intervention Group |
Primary outcome
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
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).
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).
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)
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based breathing therapy program in people with Palliative Supportive Care and Care Giving Burden, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.