ColonoscopyNCT05823350
The Effect of Abdominal Massage on Pain and Distention After Colonoscopy
A study testing Abdominal massage in people with Colonoscopy and Pain, Abdominal, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy. Methods: This randomized controlled study was conducted between October 2019 and December 2021 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonoscopy, Pain, Abdominal, Massage
- 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
- 15 Sep 2019to 15 Sep 2022
- 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
- Undergoing an elective total colonoscopy
- Having an attendant before and after the procedure
- ASA score ≤ 2
- Accepting the application of abdominal massage
Who cannot join
- Not knowing Turkish himself/herself or his/her attendant
- Having a problem that prevents the application of abdominal massage (past abdominal surgery, irritable bowel disease, bowel cancer diagnosis, gastrointestinal or urinary ostomy, etc.)
- Not wanting to have an abdominal massage
- Failure of the attendant to learn abdominal massage
- Inability to perform colonoscopy completely due to insufficient bowel preparation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Abdominal Massage on Pain and Distention in Patients Underwent Colonoscopy - A Randomized Controlled Study
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy.
Methods: This randomized controlled study was conducted between October 2019 and December 2021 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital. Thirty patients performing abdominal massage after colonoscopy were included in the experimental group.
Read the detailed description
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy.
Methods:
Settings and Design This randomized controlled experimental study was conducted between September 2019 and September 2022 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital.
The patients who underwent elective total colonoscopy, were accompanied by an attendant before and after the procedure, had an ASA score of ≤ 2, had no problem that would prevent the application of abdominal massage (past abdominal surgery, irritable bowel disease, diagnosis of bowel cancer, gastrointestinal or urinary ostomy, etc.), and accepted the application of abdominal massage after the procedure, were included in the study.
Patients who did not speak Turkish or didn't have any attendant who could speak Turkish, who did not want to receive abdominal massage, who couldn't learn abdominal massage or did not want to do it, and the patients for whom the procedure was not fully implemented due to reasons such as insufficient bowel preparation, were excluded from the study.
During the study's follow-up period, no complications related to colonoscopy were observed in the participating patients.
Data Collection Tools Patient information form and patient follow-up form were used for collecting research data. The patient information form included 3 questions investigating the sociodemographic characteristics of the patients (age, gender, experience of colonoscopy). The patient follow-up form contains four questions including the patients' pain and distension level after colonoscopy and abdominal massage. The level of pain and distension was evaluated with a 0-10 numerical comparison scale (Dreyer ve ark. 2015).
Data Collection The number of patients in each group was determined to be equal (30:30) by randomization carried out through the computer program called Research Randomiser. The group that received abdominal massage was accepted as the experimental group. On the day of the procedure, all patients who came to the endoscopy unit for a total colonoscopy were informed by the researcher about the study and then written and verbal informed consents were obtained from the patients.
In the control group, after the procedure, one relative was allowed to accompany each patient who was taken to the care room after the endoscopy. The patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy (first evaluation). The initial pain and distension levels after the procedure were recorded on the form by the researcher. The vital signs of the patients who received standard care were monitored after the procedure and were followed up for possible complications. The pain and distension levels of the patients were evaluated again 20 minutes after the first assessment (second evaluation). After the procedure, patients who met the discharge criteria were given discharge training and they were allowed to leave the endoscopy unit after the vascular access catheter was removed.
In the experimental group, the relatives of the patients were shown the video in the preparation room before the colonoscopy. The video consisted of visual and verbal content about the definition, purposes, application, and importance of the colonoscopy, the purpose of insufflation, pain management during and after the procedure, and the benefits and application steps of abdominal massage in pain management after the procedure. The video lasted 3 minutes and 19 seconds.
After the procedure, a relative was allowed to accompany each of the experimental group patients who were taken to the care room after the endoscopy. The patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy (first evaluation). The initial pain and distension levels after the procedure were recorded on the form by the researcher. Afterwards, the relatives of the patients in the experimental group were asked to apply abdominal massage to their patients. During the massage application, the patient and their relatives were observed by the researcher, and when necessary, guidance was given to the patient's relatives about the application of the massage. Liquid vaseline was used to ensure the slipperiness of the hands during the massage. In this supine position, patient's abdomen was massaged with circular movements and different techniques (kneading, vibration, efflorescence, superficial or deep strokes) in the direction of the colon.
As suggested in the literature, an abdominal massage lasted 15 minutes (Yıldırım et al. 2019). When necessary, verbal and visual guidance was provided by the researcher to ensure that the massage was performed with the correct steps and for the required time.After 5 minutes after the massage application, the researcher evaluated the patients' pain and distension levels and recorded the data on the form (second evaluation; 20 minutes after the first evaluation). After the procedure, patients who met the discharge criteria were given discharge training and they were allowed to leave the endoscopy unit after the vascular catheter was removed.
Statistical Analysis Data obtained from sixty-five patients were analyzed using the IBM SPSS 22.0 (IBM, Armonk, New York, USA) package program. Normal distribution was determined by the Kolmogorov-Smirnov test. The Mann-Whitney U test was used to compare the pain and distention scores between the two groups. Wilcoxon Signed rank test was used to compare the means of pain and distention scores within the group. The statistical significance level was accepted as p < 0.05.
- Conditions
- Colonoscopy, Pain, Abdominal, Massage, Distension; Bowel, Patients Care, Nursing
- Being tested
- Abdominal massage
- Keywords
- Abdominal massage, Colonoscopy, Abdominal pain, Patients care, Abdominal distension
- Medical subject headings
- Abdominal Pain, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageOther
Abdominal massage after colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The relatives of the patients were shown the video before the colonoscopy. The video consisted of visual and verbal content about colonoscopy, and the benefits and application steps of abdominal massage in pain management after the procedure.
After the procedure, the relatives of the patients in the experimental group were asked to apply abdominal massage to their patients. During the massage application, when necessary, guidance was given to the patient's relatives about the application of the massage. In this supine position, patient's abdomen was massaged with circular movements and different techniques in the direction of the colon. Receives: Other: Abdominal massage |
| Control Group | No intervention | After the procedure, the patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy. The vital signs of the patients who received standard care were monitored after the procedure and were followed up for possible complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain after colonoscopy
Assesment of abdominal pain after colonoscopy by using numerical pain scale (0-10)
Measured: Change from abdominal pain after the colonoscopy at 20 minutes after.
Secondary outcomes (1)
Distension after colonoscopy
Assesment of abdominal distension after colonoscopy by using numerical comparison scale (0-10)
Measured: Change from abdominal distension after the colonoscopy at 20 minutes after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start15 Sep 2019
- Primary completion15 Dec 2021
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Experimental - Randomised Controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sacide Yildizeli Topcu, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823350
- Sponsor's protocol ID
- TUTF-BAEK 2019/293
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage on Pain and Distention in Patients Underwent Colonoscopy - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05823350
- Acronym / sponsor ID
- TUTF-BAEK 2019/293
- Conditions
- Colonoscopy, Pain, Abdominal, Massage, Distension; Bowel, Patients Care, Nursing
- Keywords
- Abdominal massage, Colonoscopy, Abdominal pain, Patients care, Abdominal distension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 21 Apr 2023 (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.
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy.
Methods: This randomized controlled study was conducted between October 2019 and December 2021 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital. Thirty patients performing abdominal massage after colonoscopy were included in the experimental group.
Detailed description
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy.
Methods:
Settings and Design This randomized controlled experimental study was conducted between September 2019 and September 2022 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital.
The patients who underwent elective total colonoscopy, were accompanied by an attendant before and after the procedure, had an ASA score of ≤ 2, had no problem that would prevent the application of abdominal massage (past abdominal surgery, irritable bowel disease, diagnosis of bowel cancer, gastrointestinal or urinary ostomy, etc.), and accepted the application of abdominal massage after the procedure, were included in the study.
Patients who did not speak Turkish or didn't have any attendant who could speak Turkish, who did not want to receive abdominal massage, who couldn't learn abdominal massage or did not want to do it, and the patients for whom the procedure was not fully implemented due to reasons such as insufficient bowel preparation, were excluded from the study.
During the study's follow-up period, no complications related to colonoscopy were observed in the participating patients.
Data Collection Tools Patient information form and patient follow-up form were used for collecting research data. The patient information form included 3 questions investigating the sociodemographic characteristics of the patients (age, gender, experience of colonoscopy). The patient follow-up form contains four questions including the patients' pain and distension level after colonoscopy and abdominal massage. The level of pain and distension was evaluated with a 0-10 numerical comparison scale (Dreyer ve ark. 2015).
Data Collection The number of patients in each group was determined to be equal (30:30) by randomization carried out through the computer program called Research Randomiser. The group that received abdominal massage was accepted as the experimental group. On the day of the procedure, all patients who came to the endoscopy unit for a total colonoscopy were informed by the researcher about the study and then written and verbal informed consents were obtained from the patients.
In the control group, after the procedure, one relative was allowed to accompany each patient who was taken to the care room after the endoscopy. The patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy (first evaluation). The initial pain and distension levels after the procedure were recorded on the form by the researcher. The vital signs of the patients who received standard care were monitored after the procedure and were followed up for possible complications. The pain and distension levels of the patients were evaluated again 20 minutes after the first assessment (second evaluation). After the procedure, patients who met the discharge criteria were given discharge training and they were allowed to leave the endoscopy unit after the vascular access catheter was removed.
In the experimental group, the relatives of the patients were shown the video in the preparation room before the colonoscopy. The video consisted of visual and verbal content about the definition, purposes, application, and importance of the colonoscopy, the purpose of insufflation, pain management during and after the procedure, and the benefits and application steps of abdominal massage in pain management after the procedure. The video lasted 3 minutes and 19 seconds.
After the procedure, a relative was allowed to accompany each of the experimental group patients who were taken to the care room after the endoscopy. The patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy (first evaluation). The initial pain and distension levels after the procedure were recorded on the form by the researcher. Afterwards, the relatives of the patients in the experimental group were asked to apply abdominal massage to their patients. During the massage application, the patient and their relatives were observed by the researcher, and when necessary, guidance was given to the patient's relatives about the application of the massage. Liquid vaseline was used to ensure the slipperiness of the hands during the massage. In this supine position, patient's abdomen was massaged with circular movements and different techniques (kneading, vibration, efflorescence, superficial or deep strokes) in the direction of the colon.
As suggested in the literature, an abdominal massage lasted 15 minutes (Yıldırım et al. 2019). When necessary, verbal and visual guidance was provided by the researcher to ensure that the massage was performed with the correct steps and for the required time.After 5 minutes after the massage application, the researcher evaluated the patients' pain and distension levels and recorded the data on the form (second evaluation; 20 minutes after the first evaluation). After the procedure, patients who met the discharge criteria were given discharge training and they were allowed to leave the endoscopy unit after the vascular catheter was removed.
Statistical Analysis Data obtained from sixty-five patients were analyzed using the IBM SPSS 22.0 (IBM, Armonk, New York, USA) package program. Normal distribution was determined by the Kolmogorov-Smirnov test. The Mann-Whitney U test was used to compare the pain and distention scores between the two groups. Wilcoxon Signed rank test was used to compare the means of pain and distention scores within the group. The statistical significance level was accepted as p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental - Randomised Controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Abdominal massageThe relatives of the patients were shown the video before the colonoscopy. The video consisted of visual and verbal content about colonoscopy, and the benefits and application steps of abdominal massage in pain management after the procedure. After the procedure, the relatives of the patients in the experimental group were asked to apply abdominal massage to their patients. During the massage application, when necessary, guidance was given to the patient's relatives about the application of the massage. In this supine position, patient's abdomen was massaged with circular movements and different techniques in the direction of the colon. |
| Control Group | No intervention | –After the procedure, the patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy. The vital signs of the patients who received standard care were monitored after the procedure and were followed up for possible complications. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing an elective total colonoscopy
- Having an attendant before and after the procedure
- ASA score ≤ 2
- Accepting the application of abdominal massage
Key exclusion criteria (5 listed)
- Not knowing Turkish himself/herself or his/her attendant
- Having a problem that prevents the application of abdominal massage (past abdominal surgery, irritable bowel disease, bowel cancer diagnosis, gastrointestinal or urinary ostomy, etc.)
- Not wanting to have an abdominal massage
- Failure of the attendant to learn abdominal massage
- Inability to perform colonoscopy completely due to insufficient bowel preparation
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 after colonoscopy | Other | Experimental group |
Primary outcome
Pain after colonoscopy
Time frame: Change from abdominal pain after the colonoscopy at 20 minutes after.
Assesment of abdominal pain after colonoscopy by using numerical pain scale (0-10)
1 secondary outcome
Distension after colonoscopy
Time frame: Change from abdominal distension after the colonoscopy at 20 minutes after.
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 21 Apr 2023.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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 Colonoscopy and Pain, Abdominal, run by Trakya 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 4 inclusion and 5 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 21 Apr 2023. 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?
Pain after colonoscopy (time frame: Change from abdominal pain after the colonoscopy at 20 minutes after.). 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 21 Apr 2023.