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The Effect of TENS Application for Pain

Primary Purpose

Appendicitis Surgery, Inguinal Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS application
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis Surgery focused on measuring Transcutaneous Electric Nerve Stimulation, Child, Surgery, Pain

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TENS application

Standard pain management

Arm Description

TENS application will be applied to the experimental group before mobilization after abdominal surgery. TENS will be applied for an average of 40 minutes.

The control group will receive standard pain treatment without any intervention. The group will not receive any other intervention.

Outcomes

Primary Outcome Measures

Child Introduction Form
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).
Children's Fear Scale
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).
Children's Fear Scale
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).
Visual Analogue Scale
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.
Visual Analogue Scale
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.
The Wong-Baker Faces Pain Rating Scale
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.
The Wong-Baker Faces Pain Rating Scale
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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2021
Last Updated
September 29, 2023
Sponsor
KTO Karatay University
Collaborators
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05119621
Brief Title
The Effect of TENS Application for Pain
Official Title
The Effect of TENS Application Applied Before Mobilization on Pain in Children With Abdominal Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University
Collaborators
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Surgery, Inguinal Surgery
Keywords
Transcutaneous Electric Nerve Stimulation, Child, Surgery, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
Single Blinded
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS application
Arm Type
Experimental
Arm Description
TENS application will be applied to the experimental group before mobilization after abdominal surgery. TENS will be applied for an average of 40 minutes.
Arm Title
Standard pain management
Arm Type
No Intervention
Arm Description
The control group will receive standard pain treatment without any intervention. The group will not receive any other intervention.
Intervention Type
Device
Intervention Name(s)
TENS application
Other Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
Assigned Interventions: In addition to the standard pain management applied in the clinic, TENS will be applied to children who have had surgery.
Primary Outcome Measure Information:
Title
Child Introduction Form
Description
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).
Time Frame
(First measurement-After the operation, when the patient is taken to her bed and fully awakened)
Title
Children's Fear Scale
Description
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).
Time Frame
(First measurement-40 minutes on average before mobilization)
Title
Children's Fear Scale
Description
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).
Time Frame
(Second measurement-1 minute on average before mobilization)
Title
Visual Analogue Scale
Description
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.
Time Frame
(First measurement-40 minutes on average before mobilization)
Title
Visual Analogue Scale
Description
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.
Time Frame
(Second measurement-1 minute on average before mobilization)
Title
The Wong-Baker Faces Pain Rating Scale
Description
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.
Time Frame
(First measurement-40 minutes on average before mobilization)
Title
The Wong-Baker Faces Pain Rating Scale
Description
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.
Time Frame
(Second measurement-1 minute on average before mobilization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Metin GUNDUZ, Md.
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sibel KUCUKOGLU, PhD.
Organizational Affiliation
Selcuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hilal KURT SEZER, Lecturer
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bayram Sonmez UNUVAR
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
25227643
Citation
Ali S, Chambers A, Johnson DW, Newton AS, Vandermeer B, Williamson J, Curtis SJ. Reported practice variation in pediatric pain management: a survey of Canadian pediatric emergency physicians. CJEM. 2014 Sep;16(5):352-60. doi: 10.2310/8000.2013.131261.
Results Reference
background
Citation
Curtis S, Wingert A, Ali S. The Cochrane library and procedural pain in children: an overview of reviews. Evid Based Child Health. 2012;7(5):1363-99.
Results Reference
background
PubMed Identifier
31754300
Citation
Elboim-Gabyzon M, Andrawus Najjar S, Shtarker H. Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial. Clin Interv Aging. 2019 Oct 29;14:1841-1850. doi: 10.2147/CIA.S203658. eCollection 2019.
Results Reference
background
PubMed Identifier
25935320
Citation
Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.
Results Reference
background
PubMed Identifier
22219414
Citation
Fiorelli A, Morgillo F, Milione R, Pace MC, Passavanti MB, Laperuta P, Aurilio C, Santini M. Control of post-thoracotomy pain by transcutaneous electrical nerve stimulation: effect on serum cytokine levels, visual analogue scale, pulmonary function and medication. Eur J Cardiothorac Surg. 2012 Apr;41(4):861-8; discussion 868. doi: 10.1093/ejcts/ezr108. Epub 2011 Dec 16.
Results Reference
background
Citation
Gerçeker GÖ, Ayar D, Özdemir Z, Bektaş M. Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması DEUHFED 2018, 11 (1), 9-13
Results Reference
background
Citation
Karakoç S. Açık Kalp Cerrahisi Sonrası Klasik Metodlarla Ağrı Kontrolünün, Alternatif (TENS) Yöntemle Karşılaştırılarak, Hemşire Takip ve Kontrolün Katkısının Araştırılması. Afyon Kocatepe Üniversitesi Sağlık Bilimleri Fakültesi, Yüksek Lisans Tezi, 2009.
Results Reference
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PubMed Identifier
21806301
Citation
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
Results Reference
background
PubMed Identifier
24901753
Citation
Tokuda M, Tabira K, Masuda T, Nishiwada T, Shomoto K. Effect of modulated-frequency and modulated-intensity transcutaneous electrical nerve stimulation after abdominal surgery: a randomized controlled trial. Clin J Pain. 2014 Jul;30(7):565-70. doi: 10.1097/AJP.0b013e31829ea151.
Results Reference
background
Links:
URL
https://www.aapd.org/media/Policies_Guidelines/BP_Pain.pdf
Description
American Academy of Pediatrics, Pain Management in Infants, Children, Adolescents and Individuals with Special Health Care Needs, 2018,

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The Effect of TENS Application for Pain

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