The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children

NCT05828264 | Completed

• 1 other identifier: KU
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a randomized controlled experimental study designed to determine the effect of the Quantum-Touch method applied during the vascular access procedure in children aged 7-12 years, on the level of pain, fear and anxiety in children.

Conditions

Pain, Acute; Child Behavior; Anxiety and Fear; Venipuncture Site Reaction; Quantum

Outcome Measures

Primary Outcomes (3)

• Faces Pain Scale-Revize (FPS-R

  This scale consists of 6 facial expressions graded from 0 to 10 according to the presence and severity of pain, and its use is common in children aged 4-16. FPS-R is a valid and reliable individual expression sensitive scale in painful situations in children.

  One minute after the venipuncture procedure

• Child Fear Scale

  In this scale, the child is shown a picture containing five facial expressions evaluated between 0 and 4. 0 indicates no fear or anxiety; 4 indicates the highest fear and anxiety. These; "0" neutral expression (no anxiety) "1" little fear (very little anxiety) "2" some fear (some anxiety) "3" more fear (more anxiety) "4" highest possible fear (severe anxiety) .

  One minute after the venipuncture procedure

• Child Anxiety Scale-State

  ÇAS-D is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. The scale is aimed at children aged 4-10 years. To measure state anxiety (CAS-D), the child is asked to mark what he feels "right now".

  One minute after the venipuncture procedure

Study Arms (2)

Control group

NO INTERVENTION

children in the control group will be received standard care. Control group children will not receive any distraction techniques.

Quantum Touch

EXPERIMENTAL

The children in the quantum touch groups will received quantum touch application during the venipuncture procedure by the expert nurse

Behavioral: Quantum touch

Interventions

Quantum touch BEHAVIORAL

this group by the nurse who is included in the study and who has a practice certificate before vascular access is established. In this process, the treatment process of the patient will continue and will not create an obstacle. While the child is in a comfortable position (lying or sitting position) during the application, the child's back/shoulder/head will be touched by the practitioner and guantum touch energy will be applied. Then, vascular access will be performed by the nurse included in the study. The child will be asked to rate the level of pain during the procedure with 'FPS-R', the level of fear with 'CDS', and the level of anxiety with 'ÇAS-D'.

Quantum Touch

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child and family agree to participate in the research,
• The child's being literate,
• The child is between the ages of 7-12
• The child does not have a chronic and mental health problem.
• No history of sedative, analgesic or narcotic substance use within 24 hours before admission
• Not having a febrile illness at the time of application
• Previous vascular access

You may not qualify if:

• The child and family do not agree to participate in the research,
• The child's illiteracy,
• Having a visual and auditory problem,
• The child is less than 7 years old or older than 12 years old
• The child has a chronic and mental health problem
• Failure to open vascular access in a single attempt
• Having a phobia of pain

Sponsors & Collaborators

• Trakya University: lead
• Koç University: collaborator

Study Sites (1)

Remziye Semerci

Edirne, Center, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Child Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: this study is an experimental, parallel-group (intervention-control), randomized controlled design

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 25, 2023
• Study Start: September 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

TU (1)