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Clinical Trials/NCT05119621
NCT05119621
Completed
Not Applicable

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

KTO Karatay University1 site in 1 country50 target enrollmentStarted: July 1, 2021Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
KTO Karatay University
Enrollment
50
Locations
1
Primary Endpoint
Visual Analogue Scale

Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Single Blinded

Eligibility Criteria

Ages
7 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

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).

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.

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
KTO Karatay University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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