NCT05250544

Brief Summary

The COVID-19 pandemic continues to be one of the longest lasting pandemics experienced in recent times. Although the disease shows symptoms in different ways, the most effective diagnostic method known is the PCR test. This procedure is an unknown test method that many people have never had in their lifetime. Uncertainty in any subject causes stress and fear in the person. When the suspicion of a disease is added to this situation, the situation can reach even more serious dimensions. For this reason, it can be said that the PCR test can cause many problems, especially fear and pain. The most important health professional that the patient can reach before, during and after the test is the nurse. In order for the nurse to complete the test in a short time and with success, it may be necessary for the applicants to keep their fear levels under control and to support their fear management. In addition, the nurse plays an important role in the assessment and management of pain. In the literature review, no study was found on reducing the fear and pain of the adolescents who gave the PCR Test. It is also thought that breathing exercises and stress ball can be an advantageous method in reducing pain and fear, considering their easy accessibility, affordable cost and long-term use. For this reason, this study was planned to determine the effect of stress ball and breathing exercises on the management of fear and pain that may occur due to PCR testing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

February 10, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

January 10, 2025

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

February 10, 2022

Last Update Submit

January 9, 2025

Conditions

Keywords

Adolescentpolymerase chain reactionpainafraidstress ballbreathing exercise

Outcome Measures

Primary Outcomes (2)

  • Fear score

    Adolescents' fears will be evaluated (0-4 point)

    5 minutes

  • Pain score

    Adolescents' pain will be evaluated (0-4 point)

    5 minutes

Study Arms (2)

Stress ball group

EXPERIMENTAL

For the adolescents in the stress ball group; Before the procedure, the adolescent's fear (with Childeren's Fear Scala (CFS)) will be evaluated and recorded by the adolescent, parent and observer. Then, the stress ball will be introduced to the adolescents and they will be asked to hold it in their desired hands. After explaining how to squeeze the stress ball, the PCR Test will start a few seconds after the adolescent starts to squeeze. As soon as the process starts, the stopwatch will be started, and when the process is finished, it will be stopped. When the PCR Test starts, the crying state of the adolescent will be observed and recorded. After the procedure, the adolescent's fear (Childiren's Fear Scala (CFS)) and pain (Wong Baker FACES) related to the procedure will be evaluated separately by the adolescent, parent and observer and recorded in the form.

Other: control group

Breathin exercise group

EXPERIMENTAL

For the adolescents in the breathing exercise group; Before the procedure, the adolescent's fear (with Child's Fear Scala (CFS)) will be evaluated and recorded by the adolescent, parent and observer. Then, the breathing exercise will be introduced and applied to the adolescents. After explaining how to do the breathing exercise, the adolescent will be expected to complete the exercises. The PCR Test process will begin immediately after the exercise is complete. As soon as the process starts, the stopwatch will be started and will be stopped when the process is finished. After the procedure, the adolescent's fear (Childiren's Fear Scala (CFS)) and pain (Wong Baker FACES) related to the procedure will be evaluated separately by the adolescent, parent and observer and recorded in the form.

Other: control group

Interventions

For the adolescents in the control group; As soon as the process starts, the stopwatch will be started, and when the process is finished, it will be stopped. When the PCR Test starts, the crying state of the adolescent will be observed and recorded. After the procedure, the adolescent's fear (Childiren's Fear Scala (CFS)) and pain (Wong Baker FACES) related to the procedure will be evaluated separately by the adolescent, parent and observer and recorded in the form.

Breathin exercise groupStress ball group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The child is in the 12-18 age group,
  • PCR Test was performed by the same nurse,
  • The child has no pain (due to the disease, drug side effects, distension),
  • The child does not have a hearing problem,
  • PCR Test was performed in one go,
  • The child has no history of epilepsy, migraine or vestibular disorders,
  • Not taking analgesics in the last six hours,
  • Absence of any medication that can affect the feeling of pain and fear that he uses constantly,
  • The child and parent speak and understand Turkish comfortably,
  • The child's mental development level to be able to answer the questions asked,
  • Parents and children are willing to participate in the research,
  • Obtaining written and verbal consent from parents.

You may not qualify if:

  • Inability to perform PCR test in one go
  • Presence of a chronic disease that may affect the sense of pain and fear of the adolescent.
  • Having excessive fear and panic behavior before the procedure
  • Negative effects on communication due to fear and panic behaviors
  • Not being willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KaramanogluMehmetbeyU

Karaman, Turkey, 70100, Turkey (Türkiye)

Location

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

Related Publications (1)

  • Apaydin Cirik V, Turkmen AS, Ayaz M. Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Turkiye. J Pediatr Nurs. 2023 Jul-Aug;71:135-140. doi: 10.1016/j.pedn.2022.12.001. Epub 2022 Dec 14.

MeSH Terms

Conditions

Adolescent BehaviorAcute PainPain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 22, 2022

Study Start

March 15, 2022

Primary Completion

August 30, 2022

Study Completion

September 15, 2022

Last Updated

January 10, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations