HemodialysisNCT07402785
The Effect of Abdominal Massage on Constipation
A study testing abdominal massage in people with Hemodialysis and Constipation, run by Firat Tukenmez at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of abdominal massage on constipation in patients undergoing hemodialysis. The main questions he intends to answer are: H0: Abdominal massage applied to patients undergoing hemodialysis treatment has no effect on constipation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodialysis, Constipation
- What is being tested?
- abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to 9 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Voluntarily agreed to participate in the study
- Receiving hemodialysis treatment for at least one month
- Diagnosed with constipation by a clinician or meeting Rome IV criteria
- Able to communicate effectively and respond to all study-related questions, either personally or through a caregiver
Who cannot join
- History of ileus or intestinal perforation
- Presence of abdominal distension
- Presence of a colostomy or ileostomy
- Presence of extensive abdominal skin disease or infection
- Diagnosis of inflammatory bowel disease
- Presence of signs or symptoms of an acute abdomen
Show all 9Show fewer
- Presence of diarrhea
- Known allergy to baby oil
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Trabzon
About this study
Official title: The Effect of Abdominal Massage on Constipation in Patients Receiving Hemodialysis Treatment
This study aimed to determine the effect of abdominal massage on constipation in patients undergoing hemodialysis. The main questions he intends to answer are:
H0: Abdominal massage applied to patients undergoing hemodialysis treatment has no effect on constipation. H1: Abdominal massage applied to patients receiving hemodialysis treatment has an effect on constipation.
Read the detailed description
Participants and Setting The study population consisted of patients receiving hemodialysis treatment at the Dialysis Units of Rize Training and Research Hospital and Rize State Hospital. A total of 50 patients who met the inclusion criteria and did not meet any exclusion criteria were included in the study.
Eligible patients (n = 50) were listed and randomly assigned to either the intervention group (n = 25) or the control group (n = 25) using a simple randomization method via a computer-based program (https://randomizer.org/). One patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient. Consequently, the study was completed with 49 patients (intervention group, n = 24; control group, n = 25).
Intervention and Control Prior to the study, the researcher completed a structured training program consisting of 16 hours of theoretical education and 24 hours of practical training provided by the Department of Physical Therapy and Rehabilitation at Rize Training and Research Hospital. An official certificate confirming completion of this training was issued by the hospital administration.
Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed.
Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.
The control group did not receive abdominal massage and continued their routine treatment. In both groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week).
Statistical Analysis Data were analyzed using the Statistical Package for the Social Sciences (SPSS) for Windows, version 26.0. Distribution characteristics were assessed using skewness and kurtosis values, all of which ranged between -2 and +2, indicating normal distribution. Descriptive statistics (frequency, percentage, mean, median, and standard deviation) were used. Independent t-tests were employed for between-group comparisons, paired t-tests for within-group comparisons, and the chi-square test for categorical variables. Parametric statistical methods were applied, and a p-value < 0.05 was considered statistically significant.
- Conditions
- Hemodialysis, Constipation
- Being tested
- abdominal massage
- Keywords
- 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 massageOther
Abdominal massage is considered a promising complementary approach for alleviating the symptoms of chronic constipation due to its noninvasive nature and relatively low cost. This intervention is thought to stimulate somato-autonomic reflexes and intestinal motility, thereby enhancing peristalsis and promoting contractions of the rectal muscles. Through massage application, bowel movements become more active. In addition, abdominal massage exerts effects on the abdominal muscles and the large intestine, and by stimulating the abdominal nerve plexus (splanchnic plexus), it alters intestinal tone. As a result of these mechanisms, constipation-related symptoms such as pain and discomfort are reduced.
| Study group | Role | What they receive |
|---|---|---|
| control group (n = 25) | No intervention | The control group did not receive abdominal massage and continued their routine treatment. In groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week). For evaluation Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher. |
| intervention group (n = 24) | Experimental | One patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient.Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed.
Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher. Receives: Other: abdominal massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Severity
change in constipation severity measured using the Constipation Severity Scale
Measured: baseline and end of week 6
Secondary outcomes (2)
Constipation-related Quality of Life
Change in quality of life measured using the Constipation Quality of Lise Questionnaire.
Measured: Baseline and end of week 6
Stool Consistency
Stool from assessed using the Bristol Stool Form Scale.
Measured: Baseline and end of week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start2 Jun 2025
- Primary completion20 Jun 2025
- Study completion9 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- This study was designed as a randomized controlled clinical trial with an experimental, pretest-posttest design.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat Tukenmez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Firat Tukenmez, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402785
- Sponsor's protocol ID
- KTU-SBE-FT-01
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality of the study Participant confidentiality was strictly maintained throughout the study. All personal and clinical data were anonymized by assigning unique identification codes to each participant, and no identifying information was included in the data collection forms or analysis. Study data were accessible only to the research team and were stored securely in accordance with institutional and ethical guidelines. The results were reported in aggregate form to ensure that individual participants could not be identified.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Constipation in Patients Receiving Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT07402785
- Acronym / sponsor ID
- KTU-SBE-FT-01
- Conditions
- Hemodialysis, Constipation
- Keywords
- abdominal massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Firat TukenmezUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 9 Aug 2025 (actual)
- First posted
- 11 Feb 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.
This study aimed to determine the effect of abdominal massage on constipation in patients undergoing hemodialysis. The main questions he intends to answer are:
H0: Abdominal massage applied to patients undergoing hemodialysis treatment has no effect on constipation. H1: Abdominal massage applied to patients receiving hemodialysis treatment has an effect on constipation.
Detailed description
Participants and Setting The study population consisted of patients receiving hemodialysis treatment at the Dialysis Units of Rize Training and Research Hospital and Rize State Hospital. A total of 50 patients who met the inclusion criteria and did not meet any exclusion criteria were included in the study.
Eligible patients (n = 50) were listed and randomly assigned to either the intervention group (n = 25) or the control group (n = 25) using a simple randomization method via a computer-based program (https://randomizer.org/). One patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient. Consequently, the study was completed with 49 patients (intervention group, n = 24; control group, n = 25).
Intervention and Control Prior to the study, the researcher completed a structured training program consisting of 16 hours of theoretical education and 24 hours of practical training provided by the Department of Physical Therapy and Rehabilitation at Rize Training and Research Hospital. An official certificate confirming completion of this training was issued by the hospital administration.
Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed.
Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher.
The control group did not receive abdominal massage and continued their routine treatment. In both groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week).
Statistical Analysis Data were analyzed using the Statistical Package for the Social Sciences (SPSS) for Windows, version 26.0. Distribution characteristics were assessed using skewness and kurtosis values, all of which ranged between -2 and +2, indicating normal distribution. Descriptive statistics (frequency, percentage, mean, median, and standard deviation) were used. Independent t-tests were employed for between-group comparisons, paired t-tests for within-group comparisons, and the chi-square test for categorical variables. Parametric statistical methods were applied, and a p-value < 0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as a randomized controlled clinical trial with an experimental, pretest-posttest design.
| Arm | Type | Receives |
|---|---|---|
| control group (n = 25) | No intervention | –The control group did not receive abdominal massage and continued their routine treatment. In groups, outcome measures were assessed at baseline (first week) and at the end of the study period (sixth week). For evaluation Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher. |
| intervention group (n = 24) | Experimental | Other: abdominal massageOne patient in the intervention group died one month after the initiation of the study, and the intervention was discontinued for this patient.Abdominal massage was administered to the intervention group during hemodialysis sessions in the dialysis units of the respective hospitals, without interrupting the treatment process. Patient privacy was ensured using a curtain before each session. Massage was applied at least 30 minutes after meals. Before each session, patients' general physical and mental condition, vital signs, abdominal tension/sensitivity, and skin integrity were assessed. Abdominal massage was performed by the researcher twice weekly for six weeks, with each session lasting 15 minutes, for a total of 12 sessions. At the end of the sixth week, the effectiveness of the intervention was evaluated using the Bristol Stool Form Scale, Constipation Severity Scale, and Constipation Quality of Life Questionnaire, administered face-to-face by the researcher. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Voluntarily agreed to participate in the study
- Receiving hemodialysis treatment for at least one month
- Diagnosed with constipation by a clinician or meeting Rome IV criteria
- Able to communicate effectively and respond to all study-related questions, either personally or through a caregiver
Key exclusion criteria (9 listed)
- History of ileus or intestinal perforation
- Presence of abdominal distension
- Presence of a colostomy or ileostomy
- Presence of extensive abdominal skin disease or infection
- Diagnosis of inflammatory bowel disease
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 is considered a promising complementary approach for alleviating the symptoms of chronic constipation due to its noninvasive nature and relatively low cost. This intervention is thought to stimulate somato-autonomic reflexes and intestinal motility, thereby enhancing peristalsis and promoting contractions of the rectal muscles. Through massage application, bowel movements become more active. In addition, abdominal massage exerts effects on the abdominal muscles and the large intestine, and by stimulating the abdominal nerve plexus (splanchnic plexus), it alters intestinal tone. As a result of these mechanisms, constipation-related symptoms such as pain and discomfort are reduced. | Other | intervention group (n = 24) |
Primary outcome
Constipation Severity
Time frame: baseline and end of week 6
change in constipation severity measured using the Constipation Severity Scale
2 secondary outcomes
Constipation-related Quality of Life
Time frame: Baseline and end of week 6
Stool Consistency
Time frame: Baseline and end of week 6
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 11 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Confidentiality of the study Participant confidentiality was strictly maintained throughout the study. All personal and clinical data were anonymized by assigning unique identification codes to each participant, and no identifying information was included in the data collection forms or analysis. Study data were accessible only to the research team and were stored securely in accordance with institutional and ethical guidelines. The results were reported in aggregate form to ensure that individual participants could not be identified.
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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 Hemodialysis and Constipation, run by Firat Tukenmez 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 5 inclusion and 9 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 11 Feb 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?
Constipation Severity (time frame: baseline and end of week 6). 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 11 Feb 2026.