ConstipationNCT07570004
The Effect of Preoperative Abdominal Massage on Postoperative Constipation
A study testing Abdominal Massage in people with Constipation and Stool, run by Burcu Ozkan at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are: Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Stool
- What is being tested?
- Abdominal Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 23 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being hospitalized in the General Surgery Department
- Experiencing constipation
- Being 18 years of age or older
- Having the cognitive ability to answer questions
- Voluntary participation in the study
Who cannot join
- Being under 18 years of age
- Not experiencing constipation
- Having a condition that contraindicates abdominal massage (active intra-abdominal pathology, open wound, thrombocytopenia, etc.)
- Insufficient cognitive ability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Istanbul
About this study
Official title: The Effect of Preoperative Abdominal Massage on The Development of Postoperative Constipation: A Randomised Controlled Study
The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are:
- Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent constipation? To see if abdominal massage is effective in preventing constipation, researchers will not apply any treatment to the second group and will compare the two groups.
Read more
Participants will:
- Provide researchers with information about their preoperative and postoperative stool consistency and constipation status.
- Inform the researchers if the group that received the massage experiences any adverse effects from the massage.
Read the detailed description
Abdominal massage, being a low-cost, non-invasive procedure with no known harmful side effects, and one that nurses can integrate into clinical practice, plays an important role in the management of constipation.
This study is a single-center, randomized controlled experimental trial planned to be conducted in the General Surgery Department of a Training and Research Hospital in Istanbul. Standard operating procedures for patient recruitment, data collection, data management, adverse event reporting, and change management processes have been predefined. The experimental group will receive abdominal massage twice daily for 15 minutes, while the control group will continue with routine care. Adverse events will be recorded after each session, and necessary protocol changes will be documented in accordance with formal change management procedures. The sample size was determined based on a power analysis performed with G*Power 3.1; 30 participants were planned for each group (total n=60; α=0.05, power=0.80). A complete case analysis approach will be adopted for missing data resulting from data inconsistencies, out-of-range results, or unanswered items, and group assignments will continue until data is complete. In accordance with the statistical analysis plan, the Mann-Whitney U test will be used for between-group comparisons and the Wilcoxon test for within-group comparisons for the Bristol Stool Scale (BSS) score, which is the primary outcome measure; For the secondary outcome measure, stool type distribution, the Chi-square test will be applied. Effect size will be reported using Cohen's d and odds ratio, and the statistical significance threshold will be set at p<0.05.
- Conditions
- Constipation, Stool
- Being tested
- Abdominal Massage
- Keywords
- Preoperative, Nursing intervention, Surgery, Abdominal massage, Postoperative, Constipation
- 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
The procedure will be followed using a protocol prepared by researchers based on a literature review. Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal. The massage duration is 15 minutes. The frequency of massage is twice a day. Necessary tools and equipment include liquid petroleum jelly and a towel. The massage techniques include effleurage (superficial and deep), petrissage, and vibration.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage İnterventional Group | Experimental | Massage Group Receives: Other: Abdominal Massage |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSS score
According to the Bristol Stool Scale, a score of 1-2 indicates "hard stools," 3-4-5 indicates "normal stools," and 6-7 indicates "soft-watery stools (diarrhea)."
Measured: BSS score preoperative period and postoperative 24. hour
Secondary outcomes (1)
Stool type distribution/constipation
Stool type: hard/normal
Measured: preoperative period and postoperative 24. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jan 2026
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The procedure will be followed using a protocol prepared by researchers based on a literature review. Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal. The massage duration is 15 minutes. The frequency of massage is twice a day. Necessary tools and equipment include liquid petroleum jelly and a towel. The massage techniques include effleurage (superficial and deep), petrissage, and vibration.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burcu Ozkan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Burcu Ozkan, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570004
- Sponsor's protocol ID
- 24/11/2022-984
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Celik S, Atar NY, Ozturk N, Mendes G, Kuytak F, Bakar E, Dalgiran D, Ergin S. Constipation Risk in Patients Undergoing Abdominal Surgery. Iran Red Crescent Med J. 2015 Jun 23;17(6):e23632. doi: 10.5812/ircmj.23632. eCollection 2015 Jun.
PubMed 263801071. Olgun S, Eser I. The effect of abdominal massage on chronic constipation and constipation quality of life in elderly: a randomized controlled trial. Int J Med Res Health Sci. 2021;10(6):20-30.
McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
PubMed 21520798
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Abdominal Massage on The Development of Postoperative Constipation: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07570004
- Acronym / sponsor ID
- 24/11/2022-984
- Conditions
- Constipation, Stool
- Keywords
- Preoperative, Nursing intervention, Surgery, Abdominal massage, Postoperative, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Burcu OzkanUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 6 May 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.
The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are:
- Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent constipation? To see if abdominal massage is effective in preventing constipation, researchers will not apply any treatment to the second group and will compare the two groups.
Participants will:
- Provide researchers with information about their preoperative and postoperative stool consistency and constipation status.
- Inform the researchers if the group that received the massage experiences any adverse effects from the massage.
Detailed description
Abdominal massage, being a low-cost, non-invasive procedure with no known harmful side effects, and one that nurses can integrate into clinical practice, plays an important role in the management of constipation.
This study is a single-center, randomized controlled experimental trial planned to be conducted in the General Surgery Department of a Training and Research Hospital in Istanbul. Standard operating procedures for patient recruitment, data collection, data management, adverse event reporting, and change management processes have been predefined. The experimental group will receive abdominal massage twice daily for 15 minutes, while the control group will continue with routine care. Adverse events will be recorded after each session, and necessary protocol changes will be documented in accordance with formal change management procedures. The sample size was determined based on a power analysis performed with G*Power 3.1; 30 participants were planned for each group (total n=60; α=0.05, power=0.80). A complete case analysis approach will be adopted for missing data resulting from data inconsistencies, out-of-range results, or unanswered items, and group assignments will continue until data is complete. In accordance with the statistical analysis plan, the Mann-Whitney U test will be used for between-group comparisons and the Wilcoxon test for within-group comparisons for the Bristol Stool Scale (BSS) score, which is the primary outcome measure; For the secondary outcome measure, stool type distribution, the Chi-square test will be applied. Effect size will be reported using Cohen's d and odds ratio, and the statistical significance threshold will be set at p<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The procedure will be followed using a protocol prepared by researchers based on a literature review. Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal. The massage duration is 15 minutes. The frequency of massage is twice a day. Necessary tools and equipment include liquid petroleum jelly and a towel. The massage techniques include effleurage (superficial and deep), petrissage, and vibration.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage İnterventional Group | Experimental | Other: Abdominal MassageMassage Group |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being hospitalized in the General Surgery Department
- Experiencing constipation
- Being 18 years of age or older
- Having the cognitive ability to answer questions
- Voluntary participation in the study
Key exclusion criteria (4 listed)
- Being under 18 years of age
- Not experiencing constipation
- Having a condition that contraindicates abdominal massage (active intra-abdominal pathology, open wound, thrombocytopenia, etc.)
- Insufficient cognitive ability
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 MassageThe procedure will be followed using a protocol prepared by researchers based on a literature review. Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal. The massage duration is 15 minutes. The frequency of massage is twice a day. Necessary tools and equipment include liquid petroleum jelly and a towel. The massage techniques include effleurage (superficial and deep), petrissage, and vibration. | Other | Abdominal Massage İnterventional Group |
Primary outcome
BSS score
Time frame: BSS score preoperative period and postoperative 24. hour
According to the Bristol Stool Scale, a score of 1-2 indicates "hard stools," 3-4-5 indicates "normal stools," and 6-7 indicates "soft-watery stools (diarrhea)."
1 secondary outcome
Stool type distribution/constipation
Time frame: preoperative period and postoperative 24. hour
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 8 May 2026.
- Background: PubMed 26380107Celik S, Atar NY, Ozturk N, Mendes G, Kuytak F, Bakar E, Dalgiran D, Ergin S. Constipation Risk in Patients Undergoing Abdominal Surgery. Iran Red Crescent Med J. 2015 Jun 23;17(6):e23632. doi: 10.5812/ircmj.23632. eCollection 2015 Jun.
- Background1. Olgun S, Eser I. The effect of abdominal massage on chronic constipation and constipation quality of life in elderly: a randomized controlled trial. Int J Med Res Health Sci. 2021;10(6):20-30.
- Background: PubMed 21520798McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
- Individual participant dataSharing planned: Yes
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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 Stool, run by Burcu Ozkan 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 4 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 8 May 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?
BSS score (time frame: BSS score preoperative period and postoperative 24. hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07570004, which also lists 3 linked publications.
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 8 May 2026.