The Effect of TENS Application for Pain

September 29, 2023 updated by: KTO Karatay University

The Effect of TENS Application Applied Before Mobilization on Pain in Children With Abdominal Surgery: A Randomized Controlled Trial

The aim of the study which was planned in a randomized controlled experimental design, it was aimed to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) application on pain level before mobilization in the postoperative period in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children can often experience chronic muscle, bone, joint pain, headache and abdominal pain, and acutely experience pain due to postoperative and procedural procedures. Effective management of childhood pain is emphasized as a health priority by the World Health Organization and pain communities. The findings of various epidemiological studies emphasized that a significant proportion (49% to 64%) of children receiving treatment in a hospital setting received inadequate pain management services despite the increase in available knowledge and treatments. One of the situations in which pediatric patients encounter acute pain is the postoperative period. Mobilization is delayed in patients who cannot provide adequate pain control, and accordingly, serious complications such as impaired tissue perfusion, atelectasis and deep vein thrombosis may develop. There are studies on the use of TENS, one of the methods used in non-pharmacological pain management, in postoperative pain management in adults. Studies on pain management in children for TENS application are very limited today. There was no evidence for the effectiveness of TENS application applied before mobilization in the postoperative period in children.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • 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
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42250
        • Selcuk 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

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be in the 7-12 age range
  • Abdominal surgery indication (appendicitis or inguinal region surgery)
  • Volunteering to participate in the study
  • Receiving monotherapy treatment for epilepsy
  • To be able to communicate in Turkish

Exclusion Criteria:

  • Administering analgesic therapy other than routine administration
  • Patients who have difficulties in mobilization/complications during the operation will be 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS application
TENS application will be applied to the experimental group before mobilization after abdominal surgery. TENS will be applied for an average of 40 minutes.
Device: TENS application
Assigned Interventions: In addition to the standard pain management applied in the clinic, TENS will be applied to children who have had surgery.
Other Names:
  • Transcutaneous Electrical Nerve Stimulation
No Intervention: Standard pain management
The control group will receive standard pain treatment without any intervention. The group will not receive any other intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Introduction Form
Time Frame: (First measurement-After the operation, when the patient is taken to her bed and fully awakened)
The introductory information form was prepared by the researcher in line with the literature information. The introductory information form consists of 10 questions covering the characteristics of children and their families (age, gender, parental age, education level, family type, income status), and operational characteristics (patient's complaints, type of surgery, previous operation experience).
(First measurement-After the operation, when the patient is taken to her bed and fully awakened)
Children's Fear Scale
Time Frame: (First measurement-40 minutes on average before mobilization)
The mean score of the scale, which was translated into Turkish by five independent linguists, was 1.9 ± 0.1 (min=0, max=4). The scale can also be scored by the parent and the researcher. The scale consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).
(First measurement-40 minutes on average before mobilization)
Children's Fear Scale
Time Frame: (Second measurement-1 minute on average before mobilization)
The mean score of the scale, which was translated into Turkish by five independent linguists, was 1.9 ± 0.1 (min=0, max=4). The scale can also be scored by the parent and the researcher. The scale consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).
(Second measurement-1 minute on average before mobilization)
Visual Analogue Scale
Time Frame: (First measurement-40 minutes on average before mobilization)
The scale consists of a horizontal or vertical ruler, 10 cm or 100 mm in length, showing "painlessness" at one end and "the most severe pain" at the other end. For children over the age of six, this scale is reported to be an easy-to-understand and easy-to-apply scale.
(First measurement-40 minutes on average before mobilization)
Visual Analogue Scale
Time Frame: (Second measurement-1 minute on average before mobilization)
The scale consists of a horizontal or vertical ruler, 10 cm or 100 mm in length, showing "painlessness" at one end and "the most severe pain" at the other end. For children over the age of six, this scale is reported to be an easy-to-understand and easy-to-apply scale.
(Second measurement-1 minute on average before mobilization)
The Wong-Baker Faces Pain Rating Scale
Time Frame: (First measurement-40 minutes on average before mobilization)
In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, pain tolerance decreases, and as the score decreases, the tolerance increases.
(First measurement-40 minutes on average before mobilization)
The Wong-Baker Faces Pain Rating Scale
Time Frame: (Second measurement-1 minute on average before mobilization)
In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, pain tolerance decreases, and as the score decreases, the tolerance increases.
(Second measurement-1 minute on average before mobilization)

Collaborators and Investigators

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

Sponsor

KTO Karatay University

Collaborators

Selcuk University

Investigators

  • Study Director: Metin GUNDUZ, Md., Selcuk University
  • Study Chair: Sibel KUCUKOGLU, PhD., Selcuk University
  • Principal Investigator: Hilal KURT SEZER, Lecturer, KTO Karatay University
  • Principal Investigator: Bayram Sonmez UNUVAR, KTO Karatay University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 1, 2021

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

September 3, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KaratayUh01a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published.

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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