Appendicitis SurgeryNCT05119621
The Effect of TENS Application for Pain
A study testing TENS application in people with Appendicitis Surgery and Inguinal Surgery, run by KTO Karatay University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Appendicitis Surgery, Inguinal Surgery
- What is being tested?
- TENS application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 14 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Administering analgesic therapy other than routine administration
- Patients who have difficulties in mobilization/complications during the operation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of TENS Application Applied Before Mobilization on Pain in Children With Abdominal Surgery: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Appendicitis Surgery, Inguinal Surgery
- Being tested
- TENS application
- Keywords
- Transcutaneous Electric Nerve Stimulation, Child, Surgery, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS applicationDevice
Also called Transcutaneous Electrical Nerve Stimulation
Assigned Interventions: In addition to the standard pain management applied in the clinic, TENS will be applied to children who have had surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: (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).
Measured: (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).
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (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.
Measured: (Second measurement-1 minute on average before mobilization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Jul 2021
- Primary completion1 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Appendicitis SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- Selcuk University
- Responsible party
- Sponsor
- Investigators
- Metin GUNDUZ, Md., Study director, Selcuk UniversitySibel KUCUKOGLU, PhD., Study chair, Selcuk UniversityHilal KURT SEZER, Lecturer, Principal investigator, KTO Karatay UniversityBayram Sonmez UNUVAR, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119621
- Sponsor's protocol ID
- KaratayUh01a
- Status last verified
- Oct 2022
- First submitted
- 3 Sep 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
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.
PubMed 25227643Curtis 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.
PubMed 31754300Engen 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.
PubMed 25935320Fiorelli 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.
PubMed 22219414Gerçeker GÖ, Ayar D, Özdemir Z, Bektaş M. Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması DEUHFED 2018, 11 (1), 9-13
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.
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.
PubMed 21806301Tokuda 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.
PubMed 24901753Sezer HK, Unuvar BS, Gunduz M, Kucukoglu S. Effect of transcutaneous electrical nerve stimulation on postoperative pain and fear in children undergoing abdominal surgery: a randomized controlled trial. Rev Assoc Med Bras (1992). 2026 Aug 10;72(6):e20251661. doi: 10.1590/1806-9282.20251661. eCollection 2026.
PubMed 42585421
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TENS Application Applied Before Mobilization on Pain in Children With Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05119621
- Acronym / sponsor ID
- KaratayUh01a
- Conditions
- Appendicitis Surgery, Inguinal Surgery
- Keywords
- Transcutaneous Electric Nerve Stimulation, Child, Surgery, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- Selcuk University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| TENS application | Experimental | Device: TENS applicationTENS application will be applied to the experimental group before mobilization after abdominal surgery. TENS will be applied for an average of 40 minutes. |
| Standard pain management | No intervention | –The control group will receive standard pain treatment without any intervention. The group will not receive any other intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Administering analgesic therapy other than routine administration
- Patients who have difficulties in mobilization/complications during the operation will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS applicationAlso: Transcutaneous Electrical Nerve StimulationAssigned Interventions: In addition to the standard pain management applied in the clinic, TENS will be applied to children who have had surgery. | Device | TENS application |
Primary outcome
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).
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).
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 25227643Ali 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.
- BackgroundCurtis 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: PubMed 31754300Elboim-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.
- Background: PubMed 25935320Engen 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.
- Background: PubMed 22219414Fiorelli 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.
- BackgroundGerçeker GÖ, Ayar D, Özdemir Z, Bektaş M. Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması DEUHFED 2018, 11 (1), 9-13
- BackgroundKarakoç 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: PubMed 21806301McMurtry 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.
- Background: PubMed 24901753Tokuda 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.
- Derived from this study: PubMed 42585421Sezer HK, Unuvar BS, Gunduz M, Kucukoglu S. Effect of transcutaneous electrical nerve stimulation on postoperative pain and fear in children undergoing abdominal surgery: a randomized controlled trial. Rev Assoc Med Bras (1992). 2026 Aug 10;72(6):e20251661. doi: 10.1590/1806-9282.20251661. eCollection 2026.
- American Academy of Pediatrics, Pain Management in Infants, Children, Adolescents and Individuals with Special Health Care Needs, 2018,Link provided by the sponsor.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metin GUNDUZ, Md. study director
Selcuk University
Sibel KUCUKOGLU, PhD. study chair
Selcuk University
Hilal KURT SEZER, Lecturer principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS application in people with Appendicitis Surgery and Inguinal Surgery, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Introduction Form (time frame: (First measurement-After the operation, when the patient is taken to her bed and fully awakened)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119621, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.