Foot and Abdominal Massage Applied to After Colonoscopy

March 20, 2024 updated by: Turkan Ulker, TC Erciyes University

The Effect of Foot and Abdominal Massage Applied to After Colonoscopy on Abdominal Distention, Pain and Patient Satisfaction

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 meeting inclusion criteria were assigned to intervention and control groups using a random. 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38000
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Foot massage group

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
foot massage
Experimental: Abdominal massage group

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
abdominal massage
Experimental: Foot and Abdominal massage group

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
foot and abdominal massage
No Intervention: Control group

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
abdominal pain
Time Frame: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour ]
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
Time Frame: The end of the colonoscopy (0. Min), the end of intervention 30.min., 2. hour and 4. hour
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
Time Frame: The end of intervention 4. hour
Satisfaction evaluated with the Numerical Rating Scale Scale Zero = minimum value Ten = maximum value
The end of intervention 4. hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/568

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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