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Completed

NCT Number: NCT05119621

The Effect of TENS Application for Pain

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.

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Key information

Conditions

Appendicitis Surgery Inguinal Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Selcuklu, 42250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TENS application

Device

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Collaborators

  • Selcuk University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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