ConstipationNCT07851064
Effect of Abdominal Massage on Functional Constipation in Older Adults Living in a Care Center: A Randomized Controlled Trial
A study testing Abdominal Massage in people with Constipation and Abdominal Massage, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Although constipation can occur at any age, it is a common and treatable health problem among older adults. This randomized controlled study aimed to investigate the effect of abdominal massage on constipation among older adults receiving care services in a care center. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Constipation, Abdominal Massage
- What is being tested?
- Abdominal Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 May 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older. Presence of functional constipation according to the Rome IV diagnostic criteria.
- Ability to participate in the study and provide informed consent.
Who cannot join
- Dementia or cognitive impairment that prevented participation in the study procedures.
- Presence of a colostomy. Inability to defecate physiologically due to an underlying medical condition. Any contraindication to abdominal massage. Any condition that prevented participation in the abdominal massage intervention.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Candan Nursing Home and Elderly Care Center and the Private Candan Disabled Care Center in Aydın
Aydin
About this study
Official title: Management of Functional Constipation in the Elderly With Abdominal Massage: A Randomized Controlled Trial
Objectives: Although constipation can occur at any age, it is a common and treatable health problem among older adults. This randomized controlled study aimed to investigate the effect of abdominal massage on constipation among older adults receiving care services in a care center. Methods: The study included 86 older adults who met the Rome IV diagnostic criteria for constipation and had no contraindication to abdominal massage. Participants were randomly assigned equally to intervention and control groups using simple randomization. Abdominal massage was administered to the intervention group for 15 minutes per day, five days a week, for four weeks, while no intervention was applied to the control group. Constipation severity and constipation related quality of life were assessed using the Constipation Severity Scale (CSS) and the Patient Assessment of Constipation Quality of Life (PAC-QOL). Conclusions: Abdominal massage may be a non-invasive, low-cost, and easily applicable intervention for managing constipation among older adults. Further randomized controlled trials with longer intervention and follow-up periods are warranted.
Read the detailed description
Functional constipation is a common problem among older adults and may negatively affect daily functioning and quality of life. Abdominal massage has been proposed as a simple, non-pharmacological approach that may support bowel function and alleviate constipation-related symptoms.
This randomized controlled study evaluated whether a structured abdominal massage intervention could improve constipation-related outcomes in older adults receiving care services in Aydın, Türkiye. Eligible participants were randomly assigned to an intervention group receiving abdominal massage or a control group receiving no additional intervention. The intervention consisted of 15-minute abdominal massage sessions administered five days per week for four weeks.
The study assessed constipation severity, stool characteristics, bowel movement patterns, and constipation-related quality of life. The findings were used to evaluate the potential role of abdominal massage as a non-pharmacological approach to the management of functional constipation in older adults.
- Conditions
- Constipation, Abdominal Massage
- Being tested
- Abdominal Massage
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageBehavioural
Abdominal massage was administered for 15 minutes per day, 5 days per week, for 4 consecutive weeks. The intervention was provided to older adults receiving care services and was performed according to a standardized abdominal massage procedure. The control group did not receive abdominal massage or any additional intervention during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group, Participants did not receive abdominal massage or any additional intervention during the study period. |
| Abdominal Massage | Experimental | Abdominal Massage Group, Participants received abdominal massage for 15 minutes per day, 5 days per week, for 4 weeks Receives: Behavioral: Abdominal Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessment of Constipation Quality of Life
The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a validated questionnaire designed to assess the impact of constipation and its symptoms on patients' quality of life. It evaluates four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Higher scores indicate a greater negative impact of constipation on quality of life.
Measured: At baseline and at the end of the 4-week intervention period
Constipation Severity Scale
The Constipation Severity Scale (CSS) is a validated self-report instrument used to assess the severity of constipation symptoms. It evaluates three domains: obstructive defecation, colonic inertia, and pain. Higher scores indicate greater constipation severity. The CSS is commonly used to assess changes in constipation symptoms and treatment outcomes.
Measured: At baseline and at the end of the 4-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jan 2023
- Primary completion1 Apr 2024
- Study completion30 May 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: an abdominal massage intervention group or a control group. The intervention group received abdominal massage for 15 minutes per day, 5 days per week, for 4 weeks, while the control group received no abdominal massage or additional intervention during the study period.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Muzaffer Kahveci, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851064
- Sponsor's protocol ID
- DecisionNo.10, January 24,2023
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because the data contain potentially identifiable participant information and are subject to ethical and privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Functional Constipation in the Elderly With Abdominal Massage: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07851064
- Acronym / sponsor ID
- DecisionNo.10, January 24,2023
- Conditions
- Constipation, Abdominal Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 1 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.
Objectives: Although constipation can occur at any age, it is a common and treatable health problem among older adults. This randomized controlled study aimed to investigate the effect of abdominal massage on constipation among older adults receiving care services in a care center. Methods: The study included 86 older adults who met the Rome IV diagnostic criteria for constipation and had no contraindication to abdominal massage. Participants were randomly assigned equally to intervention and control groups using simple randomization. Abdominal massage was administered to the intervention group for 15 minutes per day, five days a week, for four weeks, while no intervention was applied to the control group. Constipation severity and constipation related quality of life were assessed using the Constipation Severity Scale (CSS) and the Patient Assessment of Constipation Quality of Life (PAC-QOL). Conclusions: Abdominal massage may be a non-invasive, low-cost, and easily applicable intervention for managing constipation among older adults. Further randomized controlled trials with longer intervention and follow-up periods are warranted.
Detailed description
Functional constipation is a common problem among older adults and may negatively affect daily functioning and quality of life. Abdominal massage has been proposed as a simple, non-pharmacological approach that may support bowel function and alleviate constipation-related symptoms.
This randomized controlled study evaluated whether a structured abdominal massage intervention could improve constipation-related outcomes in older adults receiving care services in Aydın, Türkiye. Eligible participants were randomly assigned to an intervention group receiving abdominal massage or a control group receiving no additional intervention. The intervention consisted of 15-minute abdominal massage sessions administered five days per week for four weeks.
The study assessed constipation severity, stool characteristics, bowel movement patterns, and constipation-related quality of life. The findings were used to evaluate the potential role of abdominal massage as a non-pharmacological approach to the management of functional constipation in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: an abdominal massage intervention group or a control group. The intervention group received abdominal massage for 15 minutes per day, 5 days per week, for 4 weeks, while the control group received no abdominal massage or additional intervention during the study period.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group, Participants did not receive abdominal massage or any additional intervention during the study period. |
| Abdominal Massage | Experimental | Behavioral: Abdominal MassageAbdominal Massage Group, Participants received abdominal massage for 15 minutes per day, 5 days per week, for 4 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older. Presence of functional constipation according to the Rome IV diagnostic criteria.
- Ability to participate in the study and provide informed consent.
Key exclusion criteria (2 listed)
- Dementia or cognitive impairment that prevented participation in the study procedures.
- Presence of a colostomy. Inability to defecate physiologically due to an underlying medical condition. Any contraindication to abdominal massage. Any condition that prevented participation in the abdominal massage intervention.
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 |
|---|---|---|
| Abdominal MassageAbdominal massage was administered for 15 minutes per day, 5 days per week, for 4 consecutive weeks. The intervention was provided to older adults receiving care services and was performed according to a standardized abdominal massage procedure. The control group did not receive abdominal massage or any additional intervention during the study period. | Behavioural | Abdominal Massage |
Primary outcome
Patient Assessment of Constipation Quality of Life
Time frame: At baseline and at the end of the 4-week intervention period
The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a validated questionnaire designed to assess the impact of constipation and its symptoms on patients' quality of life. It evaluates four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Higher scores indicate a greater negative impact of constipation on quality of life.
Constipation Severity Scale
Time frame: At baseline and at the end of the 4-week intervention period
The Constipation Severity Scale (CSS) is a validated self-report instrument used to assess the severity of constipation symptoms. It evaluates three domains: obstructive defecation, colonic inertia, and pain. Higher scores indicate greater constipation severity. The CSS is commonly used to assess changes in constipation symptoms and treatment outcomes.
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 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because the data contain potentially identifiable participant information and are subject to ethical and privacy considerations.
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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 Abdominal Massage in people with Constipation and Abdominal Massage, run by Muğla Sıtkı Koçman 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 2 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 1 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?
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?
Patient Assessment of Constipation Quality of Life (time frame: At baseline and at the end of the 4-week intervention period). The study lists 2 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 1 Oct 2026.