Abdominal PainNCT06333535
Foot and Abdominal Massage Applied to After Colonoscopy
A study testing foot massage, abdominal massage and foot and abdominal massage in people with Abdominal Pain and Distention, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain, Distention, Satisfaction, Patient
- What is being tested?
- foot massage, abdominal massage and foot and abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 25 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being of 18 years of age and above
- Applying for colonoscopy for diagnosis and treatment,
- Being conscious and oriented to place, person and time,
- Having pain after the procedure,
- No communication barriers,
- Able to communicate in Turkish,
- Individuals who gave written consent to participate in the research were included in the study.
Who cannot join
- Having any psychiatric disease,
- Those who have previously had bowel resection or another bowel surgery,
- Those with colostomy and ileostomy,
- Those with percutaneous endoscopic gastrostomy,
- Those with Inflammatory Bowel Disease,
- Having a history of malignant intestinal obstruction in their health history,
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- Diagnosed with colon cancer,
- Those with umbilical/abdominal hernia,
- Having an open wound in the abdominal and/or foot area,
- Those with active lower gastrointestinal system bleeding,
- Those with celiac disease,
- Patients with FMF disease were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Foot and Abdominal Massage Applied to After Colonoscopy on Abdominal Distention, Pain and Patient Satisfaction
The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale
Read the detailed description
The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants meeting inclusion criteria were assigned to intervention and control groups using a random. Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale
- Conditions
- Abdominal Pain, Distention, Satisfaction, Patient
- Being tested
- foot massage, abdominal massage, foot and abdominal massage
- Medical subject headings
- Abdominal Pain, Dilatation, Pathologic, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot massageOther
foot massage
abdominal massageOther
abdominal massage
foot and abdominal massageOther
foot and abdominal massage
| Study group | Role | What they receive |
|---|---|---|
| Foot massage group | Experimental | Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out.
2nd Stage/Intervention: The patients were massaged on both feet in accordance with the foot massage instructions.
3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. .
4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded.
5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded. Receives: Other: foot massage |
| Abdominal massage group | Experimental | Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out.
2nd Stage/Intervention: The patients were massaged in the abdominal area in accordance with the abdominal massage instructions.
3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. .
4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded.
5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded. Receives: Other: abdominal massage |
| Foot and Abdominal massage group | Experimental | Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out.
2nd Stage/Intervention: The patients were massaged in the abdominal area in line with the abdominal massage instructions, and then both feet were massaged in line with the foot massage instructions.
3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded.
4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded.
5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded. Receives: Other: foot and abdominal massage |
| Control group | No intervention | Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. Stage 2/Attempt: No attempt was made. 3rd Phase / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal pain
Abdominal pain evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
Measured: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour ]
Abdominal distension
Abdominal distension evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
Measured: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour
Patient Satisfaction
Satisfaction evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
Measured: The end of intervention 4. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Jun 2023
- Primary completion1 Jan 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turkan Ulker, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333535
- Sponsor's protocol ID
- 2022/568
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot and Abdominal Massage Applied to After Colonoscopy on Abdominal Distention, Pain and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT06333535
- Acronym / sponsor ID
- 2022/568
- Conditions
- Abdominal Pain, Distention, Satisfaction, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 27 Mar 2024 (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 study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale
Detailed description
The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants meeting inclusion criteria were assigned to intervention and control groups using a random. Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Foot massage group | Experimental | Other: foot massageStage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. 2nd Stage/Intervention: The patients were massaged on both feet in accordance with the foot massage instructions. 3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. . 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded. |
| Abdominal massage group | Experimental | Other: abdominal massageStage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. 2nd Stage/Intervention: The patients were massaged in the abdominal area in accordance with the abdominal massage instructions. 3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. . 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded. |
| Foot and Abdominal massage group | Experimental | Other: foot and abdominal massageStage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. 2nd Stage/Intervention: The patients were massaged in the abdominal area in line with the abdominal massage instructions, and then both feet were massaged in line with the foot massage instructions. 3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded. |
| Control group | No intervention | –Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. Stage 2/Attempt: No attempt was made. 3rd Phase / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being of 18 years of age and above
- Applying for colonoscopy for diagnosis and treatment,
- Being conscious and oriented to place, person and time,
- Having pain after the procedure,
- No communication barriers,
Key exclusion criteria (12 listed)
- Having any psychiatric disease,
- Those who have previously had bowel resection or another bowel surgery,
- Those with colostomy and ileostomy,
- Those with percutaneous endoscopic gastrostomy,
- Those with 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 |
|---|---|---|
| foot massagefoot massage | Other | Foot massage group |
| abdominal massageabdominal massage | Other | Abdominal massage group |
| foot and abdominal massagefoot and abdominal massage | Other | Foot and Abdominal massage group |
Primary outcome
abdominal pain
Time frame: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour ]
Abdominal pain evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
Abdominal distension
Time frame: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour
Abdominal distension evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
Patient Satisfaction
Time frame: The end of intervention 4. hour
Satisfaction evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
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 27 Mar 2024.
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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 massage, abdominal massage and foot and abdominal massage in people with Abdominal Pain and Distention, run by TC Erciyes 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 7 inclusion and 12 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 27 Mar 2024. 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?
abdominal pain (time frame: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour ]). 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 27 Mar 2024.