Back to resultsThe Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
Primary Purpose
Abdominal Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Muscle Relaxation
Sponsored by
About this trial
This is an interventional supportive care trial for Abdominal Pain focused on measuring Colonoscopy, Abdominal Pain, Nursing, relaxation, exercise
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Mardin State Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04935645
Brief Title
The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
Official Title
The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mardin Artuklu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Colonoscopy, Abdominal Pain, Nursing, relaxation, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Individual Introductory Information Form
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seher Tanrıverdi
Organizational Affiliation
Mardin Artuklu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mardin State Hospital
City
Mardin
ZIP/Postal Code
47000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
can be reviewed by other researchers after the study has been published.
IPD Sharing Time Frame
data will be shared as long as they are published
IPD Sharing Access Criteria
publication page
Citations:
PubMed Identifier
27931631
Citation
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.
Results Reference
background
PubMed Identifier
11068159
Citation
Pan 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.
Results Reference
background
PubMed Identifier
17625440
Citation
Park 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.
Results Reference
background
PubMed Identifier
30784355
Citation
Steffenssen 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 Reference
background
PubMed Identifier
20064018
Citation
Lahmann 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.
Results Reference
result
Learn more about this trial
The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.
We'll reach out to this number within 24 hrs