NCT06333535

Brief Summary

The aim of this study was to determine the effect of foot and abdominal massage applied to after colonoscopy on abdominal distention, pain and patient satisfaction.This was a randomized controlled experimental study conducted at the Colonoscopy unit in Medica Faculty Hospital . Participants assigned to the intervention group-1 received foot massages after colonoscopy, participants assigned to the intervention group-2 received abdominal massages after colonoscopy and participants assigned to the intervention group-3 received foot and abdominal massages after colonoscopy. Participants assigned to the control group received only "routine care" after colonoscopy. The abdominal pain, distension and satisfaction levels of the patients evaluated using the Numerical Rating Scale

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 20, 2024

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • abdominal pain

    Abdominal pain evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value

    The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour ]

  • Abdominal distension

    Abdominal distension evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value

    The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour

  • Patient Satisfaction

    Satisfaction evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value

    The end of intervention 4. hour

Study Arms (4)

Foot massage group

EXPERIMENTAL

Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. 2nd Stage/Intervention: The patients were massaged on both feet in accordance with the foot massage instructions. 3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. . 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded.

Other: foot massage

Abdominal massage group

EXPERIMENTAL

Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. 2nd Stage/Intervention: The patients were massaged in the abdominal area in accordance with the abdominal massage instructions. 3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. . 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded.

Other: abdominal massage

Foot and Abdominal massage group

EXPERIMENTAL

Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. 2nd Stage/Intervention: The patients were massaged in the abdominal area in line with the abdominal massage instructions, and then both feet were massaged in line with the foot massage instructions. 3rd Stage / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form, Abdominal Distension NRS Scale Form and satisfaction (NRS satisfaction) scores were directed to the patients and recorded.

Other: foot and abdominal massage

Control group

NO INTERVENTION

Stage 1/Pretest: After the colonoscopy procedure, after the patients regained consciousness in the recovery unit, the Patient Introduction Form, Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were filled out. Stage 2/Attempt: No attempt was made. 3rd Phase / 30th minute: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 4th Stage / 2nd hour: Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded. 5th Stage / 4th Hour Abdominal Pain NRS Scale Form and Abdominal Distension NRS Scale Form were administered to the patients and recorded.

Interventions

foot massage

Foot massage group

abdominal massage

Abdominal massage group

foot and abdominal massage

Foot and Abdominal massage group

Eligibility Criteria

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

You may qualify if:

  • Being of 18 years of age and above
  • Applying for colonoscopy for diagnosis and treatment,
  • Being conscious and oriented to place, person and time,
  • Having pain after the procedure,
  • No communication barriers,
  • Able to communicate in Turkish,
  • Individuals who gave written consent to participate in the research were included in the study.

You may not qualify if:

  • Having any psychiatric disease,
  • Those who have previously had bowel resection or another bowel surgery,
  • Those with colostomy and ileostomy,
  • Those with percutaneous endoscopic gastrostomy,
  • Those with Inflammatory Bowel Disease,
  • Having a history of malignant intestinal obstruction in their health history,
  • Diagnosed with colon cancer,
  • Those with umbilical/abdominal hernia,
  • Having an open wound in the abdominal and/or foot area,
  • Those with active lower gastrointestinal system bleeding,
  • Those with celiac disease,
  • Patients with FMF disease were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Abdominal PainDilatation, PathologicPatient Satisfaction

Condition Hierarchy (Ancestors)

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

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
RN

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

June 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 25, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Locations