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

Primary Purpose

Pain, Acute, Child Behavior, Anxiety and Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quantum touch
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Remziye Semerci

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Quantum Touch

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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) .
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".

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
April 22, 2023
Sponsor
Trakya University
Collaborators
Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT05828264
Brief Title
The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children
Official Title
The Effect of "Quantum-Touch" on Venipuncture Pain, Fear, and Anxiety in Children Aged 7-12 Years Old; Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University
Collaborators
Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Quantum-Touch was first described by Richard Gordon and Bob Rasmusson in 1978; it activates life force energy by combining various hand positions, various breathing techniques and body awareness exercises. It is applied by directing the formed high energy field to an area of pain, stress or illness through therapeutic touch. Tully found that Quantum Touch in reducing acute and chronic pain; Walton reported that Quantum-Touch application is effective in chronic musculoskeletal pain. It is important to conduct studies with a high level of evidence investigating the effect of Quantum Touch, which is a non-pharmacological method, on pain, fear and anxiety for children of different age groups, which is easily applied during invasive procedures. Based on this information, in this study, which was planned in a randomized controlled and experimental design, it was aimed to determine the effect of the Quantum-Touch method applied during the vascular access procedure in children between the ages of 7-12 on the level of pain, fear and anxiety in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Child Behavior, Anxiety and Fear, Venipuncture Site Reaction, Quantum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
this study is an experimental, parallel-group (intervention-control), randomized controlled design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
children in the control group will be received standard care. Control group children will not receive any distraction techniques.
Arm Title
Quantum Touch
Arm Type
Experimental
Arm Description
The children in the quantum touch groups will received quantum touch application during the venipuncture procedure by the expert nurse
Intervention Type
Behavioral
Intervention Name(s)
Quantum touch
Intervention Description
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'.
Primary Outcome Measure Information:
Title
Faces Pain Scale-Revize (FPS-R
Description
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.
Time Frame
One minute after the venipuncture procedure
Title
Child Fear Scale
Description
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) .
Time Frame
One minute after the venipuncture procedure
Title
Child Anxiety Scale-State
Description
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".
Time Frame
One minute after the venipuncture procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Remziye Semerci
City
Edirne
State/Province
Center
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

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

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