ConstipationexperimentalNCT06875349
Foot Reflexology and Abdominal Massage
A study testing foot reflexology and abdominal massage in people with Constipation, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
to determine and compare the effects of foot reflexology and abdominal massage applied to elderly individuals on constipation Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- foot reflexology and abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 19 Feb 2025
- 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
- Being 65 years or older Having no movement restrictions Not using pharmacological laxatives Being diagnosed with constipation according to the ROMA IV criteria Voluntarily agreeing to participate in the study
Who cannot join
- Individuals having a condition that prevents cognitive, affective and verbal communication Having a disorder related to the nervous system and circulatory system Having an injection applied to the abdominal region during the application process Having a systematic disorder related to the GIS (diarrhea, irritable bowel syndrome, fecal impaction, incontinence, etc.) Having physiological and structural disorders that may prevent evacuation in the anus region (rectal fissure, etc.) Having any negativity in the sensory function examination test performed with a sharp-blunt hard object on the sole of the foot and abdomen Having any physiological and structural disorders related to the foot/sole of the foot
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Foot Reflexology and Abdominal Massage in Elderly on Constipation: a Randomized Controlled Trial
to determine and compare the effects of foot reflexology and abdominal massage applied to elderly individuals on constipation
Read the detailed description
This randomized controlled study examined the effects of foot reflexology and abdominal massage on constipation in 90 elderly individuals from three nursing homes. Participants were divided into three groups: reflexology, abdominal massage, and control. The intervention groups received eight sessions over three weeks, while the control group received no treatment.
- Conditions
- Constipation
- Being tested
- foot reflexology, abdominal massage
- Keywords
- constipation, reflexology, abdominal massage, randomised
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot reflexologyOther
Foot reflexology is a complementary therapy that involves applying pressure to specific points on the feet, which are believed to correspond to different organs and systems in the body. This technique aims to promote healing by improving blood circulation, reducing stress, and supporting overall well-being. Reflexology is often used to help with issues such as constipation, stress, sleep disorders, and pain management.
abdominal massageOther
Abdominal massage is a therapeutic technique that involves applying gentle pressure and circular motions to the abdominal area to stimulate digestion, improve bowel movements, and relieve discomfort. It is commonly used to help with issues such as constipation, bloating, and digestive disorders by promoting intestinal motility and blood circulation. This technique can be performed manually or with the help of tools and is often incorporated into holistic and nursing care practices.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Foot Reflexology | Experimental | In the experimental group-1, foot reflexology interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions. Receives: Other: foot reflexology |
| Group 2: Abdominal Massage | Experimental | In the experimental group-2, abdominal massage interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions. Receives: Other: abdominal massage |
| Group 3: Control | No intervention | The elderly individuals in the control group did not receive any intervention and were only monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Severity Scale
Does foot reflexology have an effect on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
Measured: Day 1 and Day 13 and Day 25
Constipation Severity Scale
Does abdominal massage have an effect on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
Measured: Day 1 and Day 13 and Day 25
Constipation Severity Scale
Is there a difference between the effects of foot reflexology and abdominal massage on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
Measured: Day 1 and Day 13 and Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Jan 2024
- Primary completion30 Dec 2024
- Study completion19 Feb 2025
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Bayram, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875349
- Sponsor's protocol ID
- 2015-KAEK-80-23-30
- Acronym
- experimental
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 13 Mar 2025
- 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 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Foot Reflexology and Abdominal Massage in Elderly on Constipation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06875349
- Acronym / sponsor ID
- experimental / 2015-KAEK-80-23-30
- Conditions
- Constipation
- Keywords
- constipation, reflexology, abdominal massage, randomised
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 13 Mar 2025 (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.
to determine and compare the effects of foot reflexology and abdominal massage applied to elderly individuals on constipation
Detailed description
This randomized controlled study examined the effects of foot reflexology and abdominal massage on constipation in 90 elderly individuals from three nursing homes. Participants were divided into three groups: reflexology, abdominal massage, and control. The intervention groups received eight sessions over three weeks, while the control group received no treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Foot Reflexology | Experimental | Other: foot reflexologyIn the experimental group-1, foot reflexology interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions. |
| Group 2: Abdominal Massage | Experimental | Other: abdominal massageIn the experimental group-2, abdominal massage interventions were applied every three days, with each session lasting 30 minutes, for a total of eight sessions. |
| Group 3: Control | No intervention | –The elderly individuals in the control group did not receive any intervention and were only monitored. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Being 65 years or older Having no movement restrictions Not using pharmacological laxatives Being diagnosed with constipation according to the ROMA IV criteria Voluntarily agreeing to participate in the study
Key exclusion criteria (1 listed)
- Individuals having a condition that prevents cognitive, affective and verbal communication Having a disorder related to the nervous system and circulatory system Having an injection applied to the abdominal region during the application process Having a systematic disorder related to the GIS (diarrhea, irritable bowel syndrome, fecal impaction, incontinence, etc.) Having physiological and structural disorders that may prevent evacuation in the anus region (rectal fissure, etc.) Having any negativity in the sensory function examination test performed with a sharp-blunt hard object on the sole of the foot and abdomen Having any physiological and structural disorders related to the foot/sole of the foot
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 |
|---|---|---|
| foot reflexologyFoot reflexology is a complementary therapy that involves applying pressure to specific points on the feet, which are believed to correspond to different organs and systems in the body. This technique aims to promote healing by improving blood circulation, reducing stress, and supporting overall well-being. Reflexology is often used to help with issues such as constipation, stress, sleep disorders, and pain management. | Other | Group 1: Foot Reflexology |
| abdominal massageAbdominal massage is a therapeutic technique that involves applying gentle pressure and circular motions to the abdominal area to stimulate digestion, improve bowel movements, and relieve discomfort. It is commonly used to help with issues such as constipation, bloating, and digestive disorders by promoting intestinal motility and blood circulation. This technique can be performed manually or with the help of tools and is often incorporated into holistic and nursing care practices. | Other | Group 2: Abdominal Massage |
Primary outcome
Constipation Severity Scale
Time frame: Day 1 and Day 13 and Day 25
Does foot reflexology have an effect on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
Constipation Severity Scale
Time frame: Day 1 and Day 13 and Day 25
Does abdominal massage have an effect on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
Constipation Severity Scale
Time frame: Day 1 and Day 13 and Day 25
Is there a difference between the effects of foot reflexology and abdominal massage on constipation in elderly individuals? Constipation Severity Scale: The total score range is 0-73, with higher scores indicating greater severity of constipation.
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 13 Mar 2025.
- 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 foot reflexology and abdominal massage in people with Constipation, run by Karadeniz Technical 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 1 inclusion and 1 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 13 Mar 2025. 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?
Constipation Severity Scale (time frame: Day 1 and Day 13 and Day 25). 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 13 Mar 2025.