NCT06344897

Brief Summary

This study was planned to determine the effect of kinesio taping (KT) applied to the abdominal area after surgery on pain and gas output in children aged 6-12 years who had open appendicitis surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
Last Updated

April 3, 2024

Status Verified

December 1, 2023

Enrollment Period

25 days

First QC Date

January 24, 2024

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Kinesio tape applying affects pain in children aged 6-12 years who have appendicitis surgery.

    Visual Analog Scale (VAS): The scale is used to measure pain intensity. The scale consists of a horizontal or vertical ruler, 10 cm or 100 mm long, showing "no pain" at one end and "the most severe pain" possible at the other end. At the left end of the line is the expression "No pain" or "Pain is completely gone", while at the right end is the expression "Unbearable pain" or "There is no decrease in pain".

    up to 6-24 hours

  • Kinesio tape applying affects fear in children aged 6-12 years who have appendicitis surgery.

    It is used to evaluate pain and anxiety in children before and during the procedure.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).

    up to 6-24 hours

Secondary Outcomes (1)

  • Kinesio taping affects gas output time in children aged 6-12 years who have appendicitis surgery

    up to 6-24 hours

Study Arms (2)

Kinesio Taping

EXPERIMENTAL

The taping process will be done immediately after appendicitis surgery. Kinesio taping will continue until child's first gas is released. In addition to the standard pain management applied in the clinic, Kinesio tape will be applied to children who have had appendicitis surgery.

Other: Kinesio taping

Control group

NO INTERVENTION

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

Interventions

After appendicitis surgery, children will receive Kinesio taping in addition to the standard pain management applied in the clinic.

Kinesio Taping

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Open appendicitis surgery was performed,
  • Are between the ages of 6-12,
  • Conscious, literate and without hearing or speech problems,
  • Children who do not have a mental disorder and agree to participate in the research will be included.

You may not qualify if:

  • Do not apply analgesic treatment other than routine application.
  • Patients who develop complications during the operation will be excluded from the study.
  • Those with acute appendicitis or Angenesis appendicitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Konya Health Application and Research Center

Konya, Karatay, 42020, Turkey (Türkiye)

Location

Related Publications (5)

  • Atalan Efkere P, Tarsuslu T. The effects of Kinesio taping on static and dynamic balance in children with down syndrome: a randomized controlled trial. Somatosens Mot Res. 2024 Jun;41(2):115-122. doi: 10.1080/08990220.2023.2183829. Epub 2023 Feb 28.

    PMID: 36852775BACKGROUND
  • Gerçeker, G., Ayar, D., Özdemir, Z., & Bektaş, M. (2018). Çocuk anksiyete skalası-durumluluk ve çocuk Korku ölçeğinin Türk diline kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 11(1), 9-13.

    BACKGROUND
  • Mohamed RA, Yousef AM, Radwan NL, Ibrahim MM. Efficacy of different approaches on quality of upper extremity function, dexterity and grip strength in hemiplegic children: a randomized controlled study. Eur Rev Med Pharmacol Sci. 2021 Sep;25(17):5412-5423. doi: 10.26355/eurrev_202109_26648.

    PMID: 34533816BACKGROUND
  • Ortiz Ramirez J, Perez de la Cruz S. Therapeutic effects of kinesio taping in children with cerebral palsy: a systematic review. Arch Argent Pediatr. 2017 Dec 1;115(6):e356-e361. doi: 10.5546/aap.2017.eng.e356. English, Spanish.

    PMID: 29087112BACKGROUND
  • Parmar ST, Dhanuka HR, Shetty DR. Effectiveness of Kinesio Taping and Exercises for Pronated Feet in Children with Neurodevelopmental Disorders: A Cross Over Study. Niger J Clin Pract. 2022 Jan;25(1):21-26. doi: 10.4103/njcp.njcp_62_21.

    PMID: 35046190BACKGROUND

MeSH Terms

Conditions

AppendicitisAcute Pain

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • İbrahim AKKOYUN, Assoc.Prof.

    University of Health Sciences Konya Health Application and Research Center

    STUDY CHAIR
  • Bayram Sonmez UNUVAR, Ph.D.

    KTO Karatay University

    PRINCIPAL INVESTIGATOR
  • Hilal KURT SEZER, Ph.D.

    Niğde Ömer Halisdemir University

    PRINCIPAL INVESTIGATOR
  • Muzaffer ERDOĞAN, Md.

    University of Health Sciences Konya Health Application and Research Center

    PRINCIPAL INVESTIGATOR
  • Sabit DERE, Md.

    University of Health Sciences Konya Health Application and Research Center

    PRINCIPAL INVESTIGATOR
  • Merve ASKIN CERAN, M.Sc.

    KTO KaratayUniversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The research is in a parallel group, single-blind randomized controlled experimental design. Simple randomization will be applied to children who have had open appendicitis surgery and meet the inclusion criteria, without any stratification in the study. In order to determine which group the 68 children who meet the sample selection criteria in the study group will be included in, numbers from 1 to 68 will be randomly distributed to 2 groups through a computer program (https://www.randomizer.org/) without number repetition. 34 patients will be assigned to the experimental group and 34 patients to the control group. Since the person who will actively apply the taping in the study is the researcher, only the children will be blinded, therefore a single blind design will be applied.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The effect of kinesio taping on pain in children aged 6-12 years who had open appendicitis surgery.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2024

First Posted

April 3, 2024

Study Start

February 25, 2024

Primary Completion

March 21, 2024

Study Completion

April 1, 2024

Last Updated

April 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

It will be shared after the article is published

Locations