NCT04935645

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

May 25, 2021

Last Update Submit

June 15, 2021

Conditions

Keywords

ColonoscopyAbdominal PainNursingrelaxationexercise

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

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.

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.

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 27931631BACKGROUND
  • 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.

    PMID: 11068159BACKGROUND
  • 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.

    PMID: 17625440BACKGROUND
  • 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.

    PMID: 30784355BACKGROUND
  • 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.

MeSH Terms

Conditions

Abdominal PainMotor Activity

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveBehavior

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Seher Tanrıverdi

    Mardin Artuklu University

    PRINCIPAL INVESTIGATOR

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

can be reviewed by other researchers after the study has been published.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
data will be shared as long as they are published
Access Criteria
publication page

Locations