NCT07761156

Brief Summary

This study is planned with a randomized controlled experimental design to determine the effects of chewing exercises during the pre-colonoscopy preparation process and abdominal massage applied after the procedure on abdominal pain and nausea symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

Same day

First QC Date

May 7, 2026

Last Update Submit

August 11, 2026

Conditions

Post-Colonoscopy Nausea and VomitingAbdominal Pain

Keywords

vomitingcolonoscopynauseaabdominal massagegum chewingabdominal pain

Outcome Measures

Primary Outcomes (6)

  • Blood pressure measument

    To measure blood pressure, the systolic and diastolic values are combined and expressed in mm/Hg.

    4 months

  • Oxygen saturation

    Oxygen saturation will be expressed as a percentage.

    4 months

  • Pulse

    The pulse rate will be measured and recorded as the number of heartbeats per minute.

    4 months

  • Pain assessment

    Pain levels will be assessed on a scale from 0 to 10, where "0" indicates no pain and "10" indicates very severe pain.

    4 months

  • Presence of Nausea Before and After Colonoscopy (yes/no)

    Nausea will be assessed based on participant self-report and recorded as a dichotomous outcome (present/absent) using the study data collection form. The presence or absence of nausea will be evaluated at three time points: before colonoscopy, after colonoscopy, and before discharge.

    4 months

  • Presence of Vomiting Before and After Colonoscopy (yes/no)

    Vomiting will be assessed based on participant self-report and/or direct observation and recorded as a dichotomous outcome (present/absent) using the study data collection form. The presence or absence of vomiting will be evaluated at three time points: before colonoscopy, after colonoscopy, and before discharge.

    4 months

Study Arms (2)

Control

NO INTERVENTION

No additional interventions were performed on the participants in this group following the colonoscopy. They received routine care.

Abdominal massage and chewing egzersize

EXPERIMENTAL

Arm Description: Patients in the experimental group will be instructed to perform chewing movements a day before the procedure during bowel preparation, as chewing is known to increase saliva flow rate via the oropharyngeal mechanism. Abdominal massage is a non-invasive, easy-to-apply method with no side effects, performed by nurses to reduce abdominal distension after colonoscopy. The researcher will apply it for 3-5 minutes when the patient is taken to the post-op recovery room after the procedure.

Other: Abdominal massage and chewing egzersize

Interventions

Abdominal massage and chewing egzersizeOTHER

Arm Description: Patients in the experimental group will be instructed to perform chewing movements a day before the procedure during bowel preparation, as chewing is known to increase saliva flow rate via the oropharyngeal mechanism. Abdominal massage is a non-invasive, easy-to-apply method with no side effects, performed by nurses to reduce abdominal distension after colonoscopy. The researcher will apply it for 3-5 minutes when the patient is taken to the post-op recovery room after the procedure.

Abdominal massage and chewing egzersize

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and older
  • Conscious oriented cooperative and open to communication
  • Literate in Turkish

You may not qualify if:

  • Under 18 years old -Malignancy
  • Inadequate bowel cleaning
  • Pregnancy or suspected pregnancy
  • Mental disability or history of mental disorders
  • Receiving psychiatric treatment or using anxiolytic medications
  • History of prior bowel surgery
  • Nausea and vomiting complaints due to other diseases such as migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sakarya University Education and Research Hospital

Sakarya, Serdivan, 54100, Turkey (Türkiye)

Location

Sakarya University

Sakarya, Serdivan, 54100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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: 21943617RESULT

  • Tanriverdi S, Parlar Kilic S. The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients. J Perianesth Nurs. 2023 Apr;38(2):224-231. doi: 10.1016/j.jopan.2022.04.013. Epub 2022 Oct 31.

    PMID: 36328945RESULT

  • Mutlu S, Yilmaz E, Sahin ST. The effect of position change and abdominal massage on anxiety, pain and distension after colonoscopy: A randomized clinical trial. Explore (NY). 2024 Jan-Feb;20(1):89-94. doi: 10.1016/j.explore.2023.06.007. Epub 2023 Jun 20.

    PMID: 37391282RESULT

  • Öztürk, D., & Gürkan, A.; 2021; The effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort and patient satisfaction: A randomized controlled study protocol. International Journal of Clinical Trials; 8(4); 301-307.

    RESULT

MeSH Terms

Conditions

VomitingAbdominal PainNausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic Manifestations

Study Officials

  • Özlem Doğu, PhD

    Sakarya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patients in the experimental group will be instructed to perform chewing movements a day before the procedure during bowel preparation, as chewing is known to increase saliva flow rate via the oropharyngeal mechanism. The educational information provided to the chewing exercise group will be based on the "Oral-Motor Exercises Brochure" published by the Ministry of Health. Participants will be asked to perform the specified exercises at least 2-3 times for a duration of 25-30 minutes the day before. Chewing is a recommended practice for generating saliva, relaxing gastric juice, and stimulating intestinal movements; thus, it is planned to alleviate the individual's post-colonoscopy gastrointestinal problems. Abdominal massage is a non-invasive, easy-to-apply method with no side effects, performed by nurses to reduce abdominal distension after colonoscopy. The researcher will apply it for 3-5 minutes when the patient is taken to the post-op recovery room after the procedure. Vital signs,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate proffessor

Study Record Dates

First Submitted

May 7, 2026

First Posted

August 12, 2026

Study Start

June 1, 2025

Primary Completion

June 1, 2025

Study Completion

September 30, 2025

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Once the study is completed, the data may be shared if requested by researchers.

Locations

TU(2)