- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828264
The Effect of "Quantum-Touch" on Pain, Fear, and Anxiety of the Children
April 22, 2023 updated by: Remziye Semerci, Trakya University
The Effect of "Quantum-Touch" on Venipuncture Pain, Fear, and Anxiety in Children Aged 7-12 Years Old; Randomized Controlled Study
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
113
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Center
-
Edirne, Center, Turkey, 22030
- Remziye Semerci
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
children in the control group will be received standard care.
Control group children will not receive any distraction techniques.
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|
Experimental: Quantum Touch
The children in the quantum touch groups will received quantum touch application during the venipuncture procedure by the expert nurse
|
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'.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Faces Pain Scale-Revize (FPS-R
Time Frame: One minute after the venipuncture procedure
|
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.
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One minute after the venipuncture procedure
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Child Fear Scale
Time Frame: One minute after the venipuncture procedure
|
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) .
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One minute after the venipuncture procedure
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Child Anxiety Scale-State
Time Frame: One minute after the venipuncture procedure
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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".
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One minute after the venipuncture procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
April 1, 2023
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
April 11, 2023
First Submitted That Met QC Criteria
April 22, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 22, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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