NCT04979351

Brief Summary

Background: Abdominal pain, distension, and discomfort are the most frequently seen side effects after colonoscopy. These side effects can cause physical and mental results and increased workloads and care costs. Additionally, the satisfaction of the patients with the colonoscopy process may affect their willingness to undergo repeated colonoscopies in the future which may be required for the surveillance of colon malignity. Currently, there are no studies evaluating the effects of abdominal massage on post colonoscopy these abdominal symptoms. The aim of this study was to evaluate the effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort, and patient satisfaction. Methods: This study was designed as a prospective randomized controlled study. Participants meeting inclusion criteria will be assigned to intervention and control groups using a random number generator. Participants assigned to the intervention group will receive abdominal massages twice a day after colonoscopy, and participants assigned to the control group will receive only "routine care". The abdominal pain, distension, discomfort, and satisfaction levels of the patients will be evaluated using the Visual Analogue Scale. Conclusions: New approaches are needed to improve the physiological and psychological health levels of patients after colonoscopy and help them return to their daily life activities and social lives faster. The trial will provide valuable evidence to inform clinical application and help evaluate the effects of the use of the relevant intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2020

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

November 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

July 10, 2021

Last Update Submit

March 12, 2025

Conditions

Keywords

Colonoscopyabdominal massageabdominal painabdominal distensionabdominal discomfortpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Abdominal pain

    Abdominal pain will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value

    The end of the second day.

Secondary Outcomes (1)

  • Abdominal distension

    The end of the second day.

Other Outcomes (2)

  • Comfort

    The end of the second day.

  • High Satisfaction

    The end of the second day.

Study Arms (2)

Abdominal Massage Group

EXPERIMENTAL

Abdominal massage for 15 minutes twice a day application.

Other: Abdominal Massage

Placebo Group

NO INTERVENTION

Abdominal massage was not applied.

Interventions

Abdominal massage will be applied twice a day.

Abdominal Massage Group

Eligibility Criteria

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

You may qualify if:

  • being of 18 years of age and above
  • owning a cell phone
  • having a body mass index below 30
  • being conscious and having location
  • people, and time orientation
  • having no communication barriers
  • being able to communicate in Turkish
  • giving written informed consent to participate in the study

You may not qualify if:

  • were receiving sedation
  • having previously received intestine resection or other intestinal surgery
  • having an uncontrolled psychopathological illness
  • receiving colonoscopy for treatment
  • having active lower gastrointestinal system bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Cemil Taşcıoğlu City Hospital

Istanbul, Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (25)

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    PMID: 30523730BACKGROUND
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    PMID: 12145595BACKGROUND
  • Erstad DJ, Krowsoski LS, Kaafarani HM. Abdominal Pain After Colonoscopy. Gastroenterology. 2017 Feb;152(3):486-487. doi: 10.1053/j.gastro.2016.08.060. Epub 2017 Jan 3. No abstract available.

    PMID: 28056353BACKGROUND
  • Yi CH, Liu TT, Lei WY, Hung JS, Chen CL. Influence of Rectal Decompression on Abdominal Symptoms and Anorectal Physiology following Colonoscopy in Healthy Adults. Gastroenterol Res Pract. 2016;2016:4101248. doi: 10.1155/2016/4101248. Epub 2016 Aug 29.

    PMID: 27651788BACKGROUND
  • Liu TT, Yi CH, Lei WY, Yu HC, Hung JS, Chen CL. Comparison of rectal suction versus rectal tube insertion for reducing abdominal symptoms immediately after unsedated colonoscopy. Endosc Int Open. 2016 Jun;4(6):E725-9. doi: 10.1055/s-0034-1392223. Epub 2015 Dec 15.

    PMID: 27336061BACKGROUND
  • Devitt J, Shellman L, Gardner K, Nichols LW. Using positioning after a colonoscopy for patient comfort management. Gastroenterol Nurs. 2011 Mar-Apr;34(2):93-100. doi: 10.1097/SGA.0b013e31820f9ac3.

    PMID: 21455041BACKGROUND
  • Kim SY, Kim HS, Park HJ. Adverse events related to colonoscopy: Global trends and future challenges. World J Gastroenterol. 2019 Jan 14;25(2):190-204. doi: 10.3748/wjg.v25.i2.190.

    PMID: 30670909BACKGROUND
  • Lynch I, Hayes A, Buffum MD, Conners EE. Insufflation using carbon dioxide versus room air during colonoscopy: comparison of patient comfort, recovery time, and nursing resources. Gastroenterol Nurs. 2015 May-Jun;38(3):211-7. doi: 10.1097/SGA.0000000000000109.

    PMID: 25946475BACKGROUND
  • Steinberg EN, Howden CW. Randomized controlled trial of rectal tube placement for the management of abdominal distension following colonoscopy. Gastrointest Endosc. 1997 Nov;46(5):444-6. doi: 10.1016/s0016-5107(97)70038-5.

    PMID: 9402119BACKGROUND
  • Hilzenrat N, Fich A, Odes HS, Krugliak P, Eidelman L, Gaspar N, Weisberg G, Rosenthal A, Delgado JL, Ginat R, Sperber AD. Does insertion of a rectal tube after colonoscopy reduce patient discomfort and improve satisfaction? Gastrointest Endosc. 2003 Jan;57(1):54-7. doi: 10.1067/mge.2003.47.

    PMID: 12518131BACKGROUND
  • Lee JG, Vigil H, Leung JW. A randomized controlled trial of total colonic decompression after colonoscopy to improve patient comfort. Am J Gastroenterol. 2001 Jan;96(1):95-100. doi: 10.1111/j.1572-0241.2001.03458.x.

    PMID: 11197295BACKGROUND
  • Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.

    PMID: 19217105BACKGROUND
  • Liu Z, Sakakibara R, Odaka T, Uchiyama T, Yamamoto T, Ito T, Hattori T. Mechanism of abdominal massage for difficult defecation in a patient with myelopathy (HAM/TSP). J Neurol. 2005 Oct;252(10):1280-2. doi: 10.1007/s00415-005-0825-9. Epub 2005 May 20. No abstract available.

    PMID: 15895308BACKGROUND
  • Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.

    PMID: 21943617BACKGROUND
  • Dehghan M, Fatehi Poor A, Mehdipoor R, Ahmadinejad M. Does abdominal massage improve gastrointestinal functions of intensive care patients with an endotracheal tube?: A randomized clinical trial. Complement Ther Clin Pract. 2018 Feb;30:122-128. doi: 10.1016/j.ctcp.2017.12.018. Epub 2017 Dec 30.

    PMID: 29389471BACKGROUND
  • McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.

    PMID: 21520798BACKGROUND
  • Arabul M, Kandemir A, Celik M, Alper E, Akpinar Z, Aslan F, Vatansever S, Unsal B. Impact of an information video before colonoscopy on patient satisfaction and anxiety. Turk J Gastroenterol. 2012;23(5):523-9. doi: 10.4318/tjg.2012.0416.

    PMID: 23161296BACKGROUND
  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PMID: 26827847BACKGROUND
  • Ayan M, Tas U, Sogut E, Arici S, Karaman S, Esen M, Demirturk F. [Comparing efficiencies of diclofenac sodium and paracetamol in patients with primary dysmenorrhea pain by using Visual Analog Scale]. Agri. 2013;25(2):78-82. doi: 10.5505/agri.2013.42103. Turkish.

    PMID: 23720082BACKGROUND
  • Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.

    PMID: 11719741BACKGROUND
  • Kjeldsen HB, Klausen TW, Rosenberg J. Preferred Presentation of the Visual Analog Scale for Measurement of Postoperative Pain. Pain Pract. 2016 Nov;16(8):980-984. doi: 10.1111/papr.12344. Epub 2015 Aug 27.

    PMID: 26310997BACKGROUND
  • Gagliese L, Weizblit N, Ellis W, Chan VWS. The measurement of postoperative pain: a comparison of intensity scales in younger and older surgical patients. Pain. 2005 Oct;117(3):412-420. doi: 10.1016/j.pain.2005.07.004.

    PMID: 16153776BACKGROUND
  • Uysal N, Eser I, Akpinar H. The effect of abdominal massage on gastric residual volume: a randomized controlled trial. Gastroenterol Nurs. 2012 Mar-Apr;35(2):117-23. doi: 10.1097/SGA.0b013e31824c235a.

    PMID: 22472671BACKGROUND
  • Altun Ugras G, Yuksel S, Isik MT, Tasdelen B, Dogan H, Mutluay O. Effect of abdominal massage on bowel evacuation in neurosurgical intensive care patients. Nurs Crit Care. 2022 Jul;27(4):558-566. doi: 10.1111/nicc.12575. Epub 2020 Nov 12.

    PMID: 33179847BACKGROUND
  • Preece J. Introducing abdominal massage in palliative care for the relief of constipation. Complement Ther Nurs Midwifery. 2002 May;8(2):101-5. doi: 10.1054/ctnm.2002.0610.

    PMID: 12188155BACKGROUND

MeSH Terms

Conditions

Abdominal PainPatient Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • DİLEK ÖZTÜRK, MSc

    specify Unaffiliated

    PRINCIPAL INVESTIGATOR
  • Aysel GÜRKAN, PhD

    specify Unaffiliated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 10, 2021

First Posted

July 28, 2021

Study Start

November 9, 2020

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Study results will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
No time limit
Access Criteria
No Access Criteria

Available IPD Datasets

Review Access
Clinical Study Report Access

Locations