ConstipationNCT07886125
Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management
A study testing Caregiver Training in Abdominal Massage in people with Constipation, run by HAMİYET KIZIL at 1 site in Turkey (Türkiye).
Trial summary
Constipation is a common and uncomfortable problem among patients receiving palliative care. Alongside usual treatment and nursing care, abdominal massage may help manage constipation. Teaching caregivers how to perform this massage may also help them feel more confident in supporting the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Caregiver Training in Abdominal Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- Aged 18 years or older.
- Hospitalized in a palliative care unit for at least two weeks.
- Experiencing constipation.
- No clinical contraindication to abdominal massage.
- No open surgical wound, percutaneous endoscopic gastrostomy (PEG), stoma, or active surgical sutures in the abdominal region.
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- Caregivers:
- Aged 18 years or older.
- Serving as the patient's primary caregiver.
- No physical or cognitive condition that prevents learning and performing abdominal massage.
- Willing to participate voluntarily in the study.
Who cannot join
- Patients:
- Constipation caused by an acute surgical or pathophysiological condition, such as ileus.
- Any clinical condition that makes abdominal massage unsafe.
- Active surgical complications in the abdominal region.
- A clinical condition that prevents completion of the study procedures.
- Caregivers:
Show all 13Show fewer
- Insufficient cognitive or physical capacity to perform the techniques taught during training.
- A health or social condition that prevents completion of the study procedures.
- Criteria for Discontinuation:
- Participant requests withdrawal from the study.
- Patient is discharged from the hospital.
- Patient dies.
- The data collection process cannot be completed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultanbeyli State Hospital
Istanbul
Halime Tamince, BSN, +90 (506) 124 50 21, halimetmnc99@gmail.com
About this study
Official title: The Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management in Palliative Care Patients and Their Caregivers
Constipation is a common and uncomfortable problem among patients receiving palliative care. Alongside usual treatment and nursing care, abdominal massage may help manage constipation. Teaching caregivers how to perform this massage may also help them feel more confident in supporting the patient.
This study aims to evaluate the effects of abdominal massage training for caregivers on patients' constipation, caregiver burden, and caregivers' confidence in contributing to patient self-care.
Read more
Patients and their primary caregivers will participate together. Both patients and caregivers must be aged 18 years or older. Patients must have constipation, have been hospitalized in a palliative care unit for at least two weeks, and have no clinical condition that prevents abdominal massage.
Participants will be randomly assigned to one of two groups. Caregivers in the intervention group will receive a single 45-minute training session that includes an explanation and a practical demonstration of abdominal massage. They will also receive a training booklet. After training, caregivers will perform abdominal massage for 15 minutes in the morning and 15 minutes in the evening, three days per week, for two weeks. Patients will continue receiving their usual treatment and care.
Patients and caregivers in the control group will continue with usual treatment and care during the study. Control-group caregivers will be offered abdominal massage training after their study participation is completed.
Patients' constipation severity and stool form, as well as caregivers' burden and confidence in contributing to patient self-care, will be assessed at the start of the study and on Days 7 and 14.
Ethical approval has been obtained from the University of Health Sciences Hamidiye Ethics Committee for Interventional Research Not Involving Drugs or Medical Devices. Institutional permission has been obtained from the study hospital before data collection. Written informed consent has been obtained from patients and caregivers. Participation is voluntary, and personal information will be kept confidential.
Read the detailed description
Constipation is an important symptom management concern in palliative care. Patients may experience constipation in association with their underlying illnesses, medication use, reduced mobility, and changes in food and fluid intake. Individualized nursing assessment and care are therefore important components of constipation management.
Abdominal massage is a nonpharmacological approach that may complement routine constipation management. Training primary caregivers to perform abdominal massage may support their active participation in care. This randomized controlled study aims to evaluate the effects of caregiver abdominal massage training and caregiver-delivered abdominal massage on constipation severity and stool form in palliative care patients, and on caregiver burden and self-efficacy in contributing to patient self-care.
The study will use a randomized controlled experimental design and will be conducted in the palliative care unit of Sultanbeyli State Hospital in Istanbul, Türkiye. Eligible patients and their primary caregivers will participate as patient-caregiver pairs. Pairs will be randomly assigned to the intervention or control group using a random number table.
Researcher Preparation and Baseline Assessment Before delivering the intervention, the researcher will complete certified abdominal massage training. The researcher will be present in the palliative care unit during study procedures to maintain communication with caregivers and support accurate completion of the data collection instruments.
After informed consent, caregivers in both groups will complete a structured information form. Baseline assessments will include the Constipation Assessment Scale (CAS) and Bristol Stool Form Scale (BSFS) for patients, and the Zarit Burden Interview and Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC) for caregivers. Completion of the data collection instruments is expected to take approximately 20 minutes.
Intervention Group Caregivers will receive one 45-minute abdominal massage training session, consisting of theoretical instruction followed by practical demonstration. The training will cover four topics: the role and importance of abdominal massage in constipation management in palliative care; its relevance to caregivers; the potential effects of abdominal massage; and the steps of the massage procedure. A training booklet will be provided at the end of the session.
Following training, caregivers will perform abdominal massage on the patient over a two-week period. Massage will be performed three days per week, twice on each scheduled day, for 15 minutes in the morning and 15 minutes in the evening. Sessions will be scheduled to avoid interference with treatment times and routine clinical activities. Baby oil will be used as a lubricant during massage. Routine treatment and nursing care will continue throughout the study.
Control Group Patients in the control group will receive routine treatment and nursing care without the study-specific abdominal massage intervention during the two-week follow-up period. After completion of study procedures, control-group caregivers will be offered abdominal massage training.
Outcome Assessment Assessments will be repeated in both groups on Days 7 and 14. Patient outcomes will include constipation severity assessed using the CAS and stool form assessed using the BSFS. Caregiver outcomes will include caregiver burden assessed using the Zarit Burden Interview and self-efficacy in contributing to patient self-care assessed using the CSE-CSC. Changes from baseline will be compared between the intervention and control groups.
Discontinuation Criteria Study participation will be discontinued if a participant requests withdrawal, the patient is discharged from hospital, the patient dies, or the data collection process cannot be completed.
Ethical Considerations Ethical approval has been obtained from the University of Health Sciences Hamidiye Ethics Committee for Interventional Research Not Involving Drugs or Medical Devices. Institutional permission has been obtained from the study hospital before data collection begins.
Eligible patients and caregivers will be informed about the study purpose, procedures, voluntary participation, confidentiality, and protection of privacy. Written informed consent will be obtained from patients and caregivers before study procedures. Personal information will be kept confidential, and participants' privacy will be protected throughout the research.
- Conditions
- Constipation
- Being tested
- Caregiver Training in Abdominal Massage
- Keywords
- constipation, caregiver, palliative care, symptom management
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Training in Abdominal MassageBehavioural
Caregivers of palliative care patients with constipation receive training from the researcher on abdominal massage. Following training, caregivers perform abdominal massage on the patients according to the study protocol over a two-week period, in addition to routine care.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-Delivered Abdominal Massage Group | Experimental | Caregivers receive abdominal massage training and perform abdominal massage on palliative care patients with constipation in addition to routine care. Receives: Behavioral: Caregiver Training in Abdominal Massage |
| Routine Care Group | No intervention | Patients who had routine care without the study-caregiver abdominal massage training or intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in constipation severity measured by the Constipation Assessment Scale
The Constipation Assessment Scale consists of 8 items, each scored from 0 to 2. The total score is calculated by summing all item scores and ranges from 0 (no constipation) to 16 (severe constipation). Higher scores indicate greater constipation severity and a worse outcome.
Measured: Baseline (Day 0), Day 7, and Day 14
Change in caregiver burden measured by the Zarit Burden Interview
The Zarit Burden Interview consists of 22 items, each scored from 0 to 4. The total score is calculated by summing all item scores and ranges from 0 to 88. Higher scores indicate greater caregiver burden and a worse outcome, whereas lower scores indicate less caregiver burden and a better outcome.
Measured: Baseline (Day 0), Day 7, and Day 14
Change in caregiver self-efficacy measured by the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC)
The Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale consists of 10 items, each rated from 1 (not confident at all) to 5 (very confident). Total scores are standardized to range from 0 to 100. Higher scores indicate greater caregiver self-efficacy in contributing to patient self-care and a better outcome.
Measured: Baseline (Day 0), Day 7, and Day 14
Secondary outcomes (1)
Change in stool form assessed using the Bristol Stool Form Scale (BSFS)
The Bristol Stool Form Scale (BSFS) classifies stools into seven types according to their appearance and consistency, ranging from Type 1 (separate hard lumps) to Type 7 (entirely liquid stool). Types 1 and 2 indicate constipation-associated stool forms, Types 3 and 4 indicate normal stool forms, and Types 5 to 7 indicate increasingly loose stool forms. Higher type numbers indicate looser stools rather than a uniformly better or worse outcome; Types 3 and 4 represent the desired stool forms. The scale does not yield a summed total score.
Measured: Baseline (Day 0), Day 7, and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start9 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Model description
- A randomized controlled periodic research design will be used in the study. Caregivers meeting the sampling criteria will be divided into groups. Subsequently, experimental and control groups will be randomly assigned using a table of random numbers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HAMİYET KIZIL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HAMİYET KIZIL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886125
- Sponsor's protocol ID
- 2026-2/9
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data from this study. Study findings will be disseminated through the master's thesis and scientific publications using aggregate results.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management in Palliative Care Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT07886125
- Acronym / sponsor ID
- 2026-2/9
- Conditions
- Constipation
- Keywords
- constipation, caregiver, palliative care, symptom management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- HAMİYET KIZILUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
Constipation is a common and uncomfortable problem among patients receiving palliative care. Alongside usual treatment and nursing care, abdominal massage may help manage constipation. Teaching caregivers how to perform this massage may also help them feel more confident in supporting the patient.
This study aims to evaluate the effects of abdominal massage training for caregivers on patients' constipation, caregiver burden, and caregivers' confidence in contributing to patient self-care.
Patients and their primary caregivers will participate together. Both patients and caregivers must be aged 18 years or older. Patients must have constipation, have been hospitalized in a palliative care unit for at least two weeks, and have no clinical condition that prevents abdominal massage.
Participants will be randomly assigned to one of two groups. Caregivers in the intervention group will receive a single 45-minute training session that includes an explanation and a practical demonstration of abdominal massage. They will also receive a training booklet. After training, caregivers will perform abdominal massage for 15 minutes in the morning and 15 minutes in the evening, three days per week, for two weeks. Patients will continue receiving their usual treatment and care.
Patients and caregivers in the control group will continue with usual treatment and care during the study. Control-group caregivers will be offered abdominal massage training after their study participation is completed.
Patients' constipation severity and stool form, as well as caregivers' burden and confidence in contributing to patient self-care, will be assessed at the start of the study and on Days 7 and 14.
Ethical approval has been obtained from the University of Health Sciences Hamidiye Ethics Committee for Interventional Research Not Involving Drugs or Medical Devices. Institutional permission has been obtained from the study hospital before data collection. Written informed consent has been obtained from patients and caregivers. Participation is voluntary, and personal information will be kept confidential.
Detailed description
Constipation is an important symptom management concern in palliative care. Patients may experience constipation in association with their underlying illnesses, medication use, reduced mobility, and changes in food and fluid intake. Individualized nursing assessment and care are therefore important components of constipation management.
Abdominal massage is a nonpharmacological approach that may complement routine constipation management. Training primary caregivers to perform abdominal massage may support their active participation in care. This randomized controlled study aims to evaluate the effects of caregiver abdominal massage training and caregiver-delivered abdominal massage on constipation severity and stool form in palliative care patients, and on caregiver burden and self-efficacy in contributing to patient self-care.
The study will use a randomized controlled experimental design and will be conducted in the palliative care unit of Sultanbeyli State Hospital in Istanbul, Türkiye. Eligible patients and their primary caregivers will participate as patient-caregiver pairs. Pairs will be randomly assigned to the intervention or control group using a random number table.
Researcher Preparation and Baseline Assessment Before delivering the intervention, the researcher will complete certified abdominal massage training. The researcher will be present in the palliative care unit during study procedures to maintain communication with caregivers and support accurate completion of the data collection instruments.
After informed consent, caregivers in both groups will complete a structured information form. Baseline assessments will include the Constipation Assessment Scale (CAS) and Bristol Stool Form Scale (BSFS) for patients, and the Zarit Burden Interview and Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC) for caregivers. Completion of the data collection instruments is expected to take approximately 20 minutes.
Intervention Group Caregivers will receive one 45-minute abdominal massage training session, consisting of theoretical instruction followed by practical demonstration. The training will cover four topics: the role and importance of abdominal massage in constipation management in palliative care; its relevance to caregivers; the potential effects of abdominal massage; and the steps of the massage procedure. A training booklet will be provided at the end of the session.
Following training, caregivers will perform abdominal massage on the patient over a two-week period. Massage will be performed three days per week, twice on each scheduled day, for 15 minutes in the morning and 15 minutes in the evening. Sessions will be scheduled to avoid interference with treatment times and routine clinical activities. Baby oil will be used as a lubricant during massage. Routine treatment and nursing care will continue throughout the study.
Control Group Patients in the control group will receive routine treatment and nursing care without the study-specific abdominal massage intervention during the two-week follow-up period. After completion of study procedures, control-group caregivers will be offered abdominal massage training.
Outcome Assessment Assessments will be repeated in both groups on Days 7 and 14. Patient outcomes will include constipation severity assessed using the CAS and stool form assessed using the BSFS. Caregiver outcomes will include caregiver burden assessed using the Zarit Burden Interview and self-efficacy in contributing to patient self-care assessed using the CSE-CSC. Changes from baseline will be compared between the intervention and control groups.
Discontinuation Criteria Study participation will be discontinued if a participant requests withdrawal, the patient is discharged from hospital, the patient dies, or the data collection process cannot be completed.
Ethical Considerations Ethical approval has been obtained from the University of Health Sciences Hamidiye Ethics Committee for Interventional Research Not Involving Drugs or Medical Devices. Institutional permission has been obtained from the study hospital before data collection begins.
Eligible patients and caregivers will be informed about the study purpose, procedures, voluntary participation, confidentiality, and protection of privacy. Written informed consent will be obtained from patients and caregivers before study procedures. Personal information will be kept confidential, and participants' privacy will be protected throughout the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled periodic research design will be used in the study. Caregivers meeting the sampling criteria will be divided into groups. Subsequently, experimental and control groups will be randomly assigned using a table of random numbers.
| Arm | Type | Receives |
|---|---|---|
| Caregiver-Delivered Abdominal Massage Group | Experimental | Behavioral: Caregiver Training in Abdominal MassageCaregivers receive abdominal massage training and perform abdominal massage on palliative care patients with constipation in addition to routine care. |
| Routine Care Group | No intervention | –Patients who had routine care without the study-caregiver abdominal massage training or intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 years or older.
- Hospitalized in a palliative care unit for at least two weeks.
- Experiencing constipation.
- No clinical contraindication to abdominal massage.
- No open surgical wound, percutaneous endoscopic gastrostomy (PEG), stoma, or active surgical sutures in the abdominal region.
Key exclusion criteria (13 listed)
- Constipation caused by an acute surgical or pathophysiological condition, such as ileus.
- Any clinical condition that makes abdominal massage unsafe.
- Active surgical complications in the abdominal region.
- A clinical condition that prevents completion of the study procedures.
- Insufficient cognitive or physical capacity to perform the techniques taught during 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 |
|---|---|---|
| Caregiver Training in Abdominal MassageCaregivers of palliative care patients with constipation receive training from the researcher on abdominal massage. Following training, caregivers perform abdominal massage on the patients according to the study protocol over a two-week period, in addition to routine care. | Behavioural | Caregiver-Delivered Abdominal Massage Group |
Primary outcome
Change in constipation severity measured by the Constipation Assessment Scale
Time frame: Baseline (Day 0), Day 7, and Day 14
The Constipation Assessment Scale consists of 8 items, each scored from 0 to 2. The total score is calculated by summing all item scores and ranges from 0 (no constipation) to 16 (severe constipation). Higher scores indicate greater constipation severity and a worse outcome.
Change in caregiver burden measured by the Zarit Burden Interview
Time frame: Baseline (Day 0), Day 7, and Day 14
The Zarit Burden Interview consists of 22 items, each scored from 0 to 4. The total score is calculated by summing all item scores and ranges from 0 to 88. Higher scores indicate greater caregiver burden and a worse outcome, whereas lower scores indicate less caregiver burden and a better outcome.
Change in caregiver self-efficacy measured by the Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale (CSE-CSC)
Time frame: Baseline (Day 0), Day 7, and Day 14
The Caregiver Self-Efficacy in Contributing to Patient Self-Care Scale consists of 10 items, each rated from 1 (not confident at all) to 5 (very confident). Total scores are standardized to range from 0 to 100. Higher scores indicate greater caregiver self-efficacy in contributing to patient self-care and a better outcome.
1 secondary outcome
Change in stool form assessed using the Bristol Stool Form Scale (BSFS)
Time frame: Baseline (Day 0), Day 7, and Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data from this study. Study findings will be disseminated through the master's thesis and scientific publications using aggregate results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Training in Abdominal Massage in people with Constipation, run by HAMİYET KIZIL 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamiyet Kızıl, PhD (+90 (536) 037 07 57, hamiyet.kizil@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in constipation severity measured by the Constipation Assessment Scale (time frame: Baseline (Day 0), Day 7, and Day 14). The study lists 3 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 26 Oct 2026.