The Effect of TENS Application for Pain

Inguinal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119621
• Other study ID #: KaratayUh01a
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 14, 2022

Study information

• Verified date: October 2022
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 14, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis
• Inguinal Surgery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (2)

Lead Sponsor	Collaborator
KTO Karatay University	Selcuk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View 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.

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. — View 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. — View 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. — View Citation

Gerçeker GÖ, Ayar D, Özdemir Z, Bektas M. Çocuk Anksiyete Skalasi-Durumluluk ve Çocuk Korku Ölçeginin Türk Diline Kazandirilmasi DEUHFED 2018, 11 (1), 9-13

Karakoç S. Açik Kalp Cerrahisi Sonrasi Klasik Metodlarla Agri Kontrolünün, Alternatif (TENS) Yöntemle Karsilastirilarak, Hemsire Takip ve Kontrolün Katkisinin Arastirilmasi. Afyon Kocatepe Üniversitesi Saglik Bilimleri Fakültesi, Yüksek Lisans Tezi, 2009.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)

External Links

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