The Effect of TENS Application for Pain

Sponsor
KTO Karatay University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05119621
Collaborator
Selcuk University (Other)
44
1
2
13
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TENS application
N/A

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
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Single (Participant)
Masking Description:
Single Blinded
Primary Purpose:
Treatment
Official Title:
The Effect of TENS Application Applied Before Mobilization on Pain in Children With Abdominal Surgery: A Randomized Controlled Trial
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Child Introduction Form [(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).

    2. Children's Fear Scale [(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).

    3. Children's Fear Scale [(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).

    4. Visual Analogue Scale [(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.

    5. Visual Analogue Scale [(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.

    6. The Wong-Baker Faces Pain Rating Scale [(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.

    7. The Wong-Baker Faces Pain Rating Scale [(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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 12 Years
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Selcuk University Konya Selcuklu Turkey 42250

    Sponsors and Collaborators

    • KTO Karatay University
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    KTO Karatay University
    ClinicalTrials.gov Identifier:
    NCT05119621
    Other Study ID Numbers:
    • KaratayUh01a
    First Posted:
    Nov 15, 2021
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by KTO Karatay University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022