The Effect of TENS Application for Pain

NCT ID: NCT05119621

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-11-14

Brief Summary

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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

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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.

Conditions

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Appendicitis Surgery Inguinal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single Blinded

Study Groups

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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.

Group Type EXPERIMENTAL

TENS application

Intervention Type DEVICE

Assigned Interventions: In addition to the standard pain management applied in the clinic, TENS will be applied to children who have had surgery.

Standard pain management

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role collaborator

KTO Karatay University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Metin GUNDUZ, Md.

Role: STUDY_DIRECTOR

Selcuk University

Sibel KUCUKOGLU, PhD.

Role: STUDY_CHAIR

Selcuk University

Hilal KURT SEZER, Lecturer

Role: PRINCIPAL_INVESTIGATOR

KTO Karatay University

Bayram Sonmez UNUVAR

Role: PRINCIPAL_INVESTIGATOR

KTO Karatay University

Locations

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Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 25227643 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 31754300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25935320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22219414 (View on PubMed)

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 21806301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24901753 (View on PubMed)

Related Links

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https://www.aapd.org/media/Policies_Guidelines/BP_Pain.pdf

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

Other Identifiers

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KaratayUh01a

Identifier Type: -

Identifier Source: org_study_id

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