Abdominal PainNCT04935645
The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
A study testing Progressive Muscle Relaxation in people with Abdominal Pain, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing colonoscopy were divided into progressive relaxation exercises and control groups. Pretest and posttest abdominal pain and distention scores of the patients were determined after colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 30 Dec 2020
- 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
- Patients undergoing colonoscopy
- Those who do not have communication problems,
- After the colonoscopy procedure, the abdominal pain score is evaluated by VAS and is 4 or higher,
- Evaluation of the distension score of 4 and above with VAS after the colonoscopy procedure,
- Be 18 years old or older.
Who cannot join
- Being a hospitalized patient undergoing colonoscopy,
- Be younger than 18 years old
- To have used complementary and alternative methods during the research,
- Any physical problem that may prevent you from doing the exercises,
- Having a cognitive illness
- Refusing to participate in the research,
- Failing to complete surveys.
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing colonoscopy were divided into progressive relaxation exercises and control groups. Pretest and posttest abdominal pain and distention scores of the patients were determined after colonoscopy.
- Conditions
- Abdominal Pain
- Being tested
- Progressive Muscle Relaxation
- Keywords
- Colonoscopy, Abdominal Pain, Nursing, relaxation, exercise
- Medical subject headings
- Abdominal Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
PMR is a technique that provides relaxation in the whole body by voluntary and regular relaxation of large muscle groups in the human body, which is included in mind-body applications.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group was informed about progressive muscle relaxation (PMR) before colonoscopy. PMR audio recordings were given to the patients. Abdominal pain and distention scores were determined after colonoscopy. PMR was applied to the patients for 30 minutes. These scores were determined again after exercise and at the 2nd, 4th, 8th, 12th, 16th, and 24th hours. Receives: Behavioral: Progressive Muscle Relaxation |
| Control Group | No intervention | VAS pain and VAS distension scores of the control group were determined after colonoscopy and 30 minutes later. VAS form was given to all patients to determine VAS abdominal pain and VAS distension scores at the 2nd, 4th, 8th, 12th, 16th and 24th hours after the procedure. The day after the colonoscopy, post test data were collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual Introductory Information Form
This form, which was created by the researcher with the support of the relevant literature, consists of 11 questions questioning the patients' education level, age,gender, employment status, marital status,income level, the coping methods they use when there is distension in their daily lives, the coping methods they use when there is pain in their daily lives, the status of having a colonoscopy before, the history of abdominal pain and distension of those who have a colonoscopy experience.
Measured: 15 minutes
Secondary outcomes (1)
Visual Analogue Scale (VAS)
The patient was asked to make a mark on a 10 cm horizontal line on the Visual analog scale showing his current state. In this study, for pain and distension; Markings were made on a 10 cm horizontal line, one end of which indicates that the patient's pain is very good (0 = no pain) and the other end is that the patient's pain is very bad (10 = most severe). The distance from the point where there was no pain and distension (0) to the point marked by the patient was measured. The value found shows the severity of pain and distention of the patient.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Jul 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies 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
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Tanrıverdi, Mardin Artuklu University
- Investigators
- Seher Tanrıverdi, Principal investigator, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935645
- Sponsor's protocol ID
- Mardin Artuklu University
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: can be reviewed by other researchers after the study has been published.
Publications
Levy I, Gralnek IM. Complications of diagnostic colonoscopy, upper endoscopy, and enteroscopy. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):705-718. doi: 10.1016/j.bpg.2016.09.005. Epub 2016 Sep 14.
PubMed 27931631Pan CX, Morrison RS, Ness J, Fugh-Berman A, Leipzig RM. Complementary and alternative medicine in the management of pain, dyspnea, and nausea and vomiting near the end of life. A systematic review. J Pain Symptom Manage. 2000 Nov;20(5):374-87. doi: 10.1016/s0885-3924(00)00190-1.
PubMed 11068159Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.
PubMed 17625440Steffenssen MW, Al-Najami I, Baatrup G. Patient-reported minor adverse events after colonoscopy: a systematic review. Acta Oncol. 2019;58(sup1):S22-S28. doi: 10.1080/0284186X.2019.1574979. Epub 2019 Feb 20.
PubMed 30784355Lahmann C, Rohricht F, Sauer N, Noll-Hussong M, Ronel J, Henrich G, von Arnim A, Loew T. Functional relaxation as complementary therapy in irritable bowel syndrome: a randomized, controlled clinical trial. J Altern Complement Med. 2010 Jan;16(1):47-52. doi: 10.1089/acm.2009.0084.
PubMed 20064018
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
- ClinicalTrials.gov ID
- NCT04935645
- Acronym / sponsor ID
- Mardin Artuklu University
- Conditions
- Abdominal Pain
- Keywords
- Colonoscopy, Abdominal Pain, Nursing, relaxation, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 23 Jun 2021 (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.
Patients undergoing colonoscopy were divided into progressive relaxation exercises and control groups. Pretest and posttest abdominal pain and distention scores of the patients were determined after colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Progressive Muscle RelaxationThe experimental group was informed about progressive muscle relaxation (PMR) before colonoscopy. PMR audio recordings were given to the patients. Abdominal pain and distention scores were determined after colonoscopy. PMR was applied to the patients for 30 minutes. These scores were determined again after exercise and at the 2nd, 4th, 8th, 12th, 16th, and 24th hours. |
| Control Group | No intervention | –VAS pain and VAS distension scores of the control group were determined after colonoscopy and 30 minutes later. VAS form was given to all patients to determine VAS abdominal pain and VAS distension scores at the 2nd, 4th, 8th, 12th, 16th and 24th hours after the procedure. The day after the colonoscopy, post test data were collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing colonoscopy
- Those who do not have communication problems,
- After the colonoscopy procedure, the abdominal pain score is evaluated by VAS and is 4 or higher,
- Evaluation of the distension score of 4 and above with VAS after the colonoscopy procedure,
- Be 18 years old or older.
Key exclusion criteria (7 listed)
- Being a hospitalized patient undergoing colonoscopy,
- Be younger than 18 years old
- To have used complementary and alternative methods during the research,
- Any physical problem that may prevent you from doing the exercises,
- Having a cognitive illness
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 |
|---|---|---|
| Progressive Muscle RelaxationPMR is a technique that provides relaxation in the whole body by voluntary and regular relaxation of large muscle groups in the human body, which is included in mind-body applications. | Behavioural | Experimental Group |
Primary outcome
Individual Introductory Information Form
Time frame: 15 minutes
This form, which was created by the researcher with the support of the relevant literature, consists of 11 questions questioning the patients' education level, age,gender, employment status, marital status,income level, the coping methods they use when there is distension in their daily lives, the coping methods they use when there is pain in their daily lives, the status of having a colonoscopy before, the history of abdominal pain and distension of those who have a colonoscopy experience.
1 secondary outcome
Visual Analogue Scale (VAS)
Time frame: 10 minutes
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 23 Jun 2021.
- Background: PubMed 27931631Levy I, Gralnek IM. Complications of diagnostic colonoscopy, upper endoscopy, and enteroscopy. Best Pract Res Clin Gastroenterol. 2016 Oct;30(5):705-718. doi: 10.1016/j.bpg.2016.09.005. Epub 2016 Sep 14.
- Background: PubMed 11068159Pan CX, Morrison RS, Ness J, Fugh-Berman A, Leipzig RM. Complementary and alternative medicine in the management of pain, dyspnea, and nausea and vomiting near the end of life. A systematic review. J Pain Symptom Manage. 2000 Nov;20(5):374-87. doi: 10.1016/s0885-3924(00)00190-1.
- Background: PubMed 17625440Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9. doi: 10.1097/01.meg.0000219097.32811.24.
- Background: PubMed 30784355Steffenssen MW, Al-Najami I, Baatrup G. Patient-reported minor adverse events after colonoscopy: a systematic review. Acta Oncol. 2019;58(sup1):S22-S28. doi: 10.1080/0284186X.2019.1574979. Epub 2019 Feb 20.
- Results publication: PubMed 20064018Lahmann C, Rohricht F, Sauer N, Noll-Hussong M, Ronel J, Henrich G, von Arnim A, Loew T. Functional relaxation as complementary therapy in irritable bowel syndrome: a randomized, controlled clinical trial. J Altern Complement Med. 2010 Jan;16(1):47-52. doi: 10.1089/acm.2009.0084.
- Individual participant dataSharing planned: Yes. can be reviewed by other researchers after the study has been published.
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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.
Seher Tanrıverdi principal investigator
Mardin Artuklu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation in people with Abdominal Pain, run by Mardin Artuklu 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 5 inclusion and 7 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 23 Jun 2021. 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?
Individual Introductory Information Form (time frame: 15 minutes). 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 NCT04935645, which also lists 5 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 23 Jun 2021.