The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
1 other identifier
interventional
90
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedJune 23, 2021
June 1, 2021
1.5 years
May 25, 2021
June 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
15 minutes
Secondary Outcomes (1)
Visual Analogue Scale (VAS)
10 minutes
Study Arms (2)
Experimental Group
EXPERIMENTALThe 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 INTERVENTIONVAS 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mardin State Hospital
Mardin, 47000, Turkey (Türkiye)
Related Publications (5)
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.
PMID: 27931631BACKGROUNDPan 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.
PMID: 11068159BACKGROUNDPark 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.
PMID: 17625440BACKGROUNDSteffenssen 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.
PMID: 30784355BACKGROUNDLahmann 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.
PMID: 20064018RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seher Tanrıverdi
Mardin Artuklu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research asistant
Study Record Dates
First Submitted
May 25, 2021
First Posted
June 23, 2021
Study Start
July 1, 2019
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
June 23, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- data will be shared as long as they are published
- Access Criteria
- publication page
can be reviewed by other researchers after the study has been published.