The Effect of TENS Application for Pain

NCT05119621 | Completed

• 1 other identifier: KaratayUh01a
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis Surgery; Inguinal Surgery

Keywords

Transcutaneous Electric Nerve Stimulation; Child; Surgery; Pain

Outcome Measures

Primary Outcomes (7)

• 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).

  (First measurement-After the operation, when the patient is taken to her bed and fully awakened)

• 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).

  (First measurement-40 minutes on average before mobilization)

• 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).

  (Second measurement-1 minute on average before mobilization)

• 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.

  (First measurement-40 minutes on average before mobilization)

• 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.

  (Second measurement-1 minute on average before mobilization)

• 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.

  (First measurement-40 minutes on average before mobilization)

• 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.

  (Second measurement-1 minute on average before mobilization)

Study Arms (2)

TENS application

EXPERIMENTAL

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

Standard pain management

NO INTERVENTION

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

Interventions

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.

Also known as: Transcutaneous Electrical Nerve Stimulation

TENS application

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Administering analgesic therapy other than routine administration
• Patients who have difficulties in mobilization/complications during the operation will be excluded from the study.

Sponsors & Collaborators

• KTO Karatay University: lead
• Selcuk University: collaborator

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42250, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 25227643 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31754300 BACKGROUND

• 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.

  PMID: 25935320 BACKGROUND

• 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.

  PMID: 22219414 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21806301 BACKGROUND

• 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.

  PMID: 24901753 BACKGROUND

Related Links

• American Academy of Pediatrics, Pain Management in Infants, Children, Adolescents and Individuals with Special Health Care Needs, 2018,

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Metin GUNDUZ, Md.

  Selcuk University

  STUDY DIRECTOR

• Sibel KUCUKOGLU, PhD.

  Selcuk University

  STUDY CHAIR

• Hilal KURT SEZER, Lecturer

  KTO Karatay University

  PRINCIPAL INVESTIGATOR

• Bayram Sonmez UNUVAR

  KTO Karatay University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: November 15, 2021
• Study Start: July 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 14, 2022
• Last Updated: October 2, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)