Clinical trial NCT05828264: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Child Behavior
Anxiety and Fear
Venipuncture Site Reaction
Quantum
Lead sponsor: Trakya University
Sponsor class: OTHER
Collaborators: name: Koç University
First posted: 2023-04-25
Enrollment: 113
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this study is an experimental, parallel-group (intervention-control), randomized controlled design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Faces Pain Scale-Revize (FPS-R
timeFrame: One minute after the venipuncture procedure
measure: Child Fear Scale
timeFrame: One minute after the venipuncture procedure
measure: Child Anxiety Scale-State
timeFrame: One minute after the venipuncture procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Remziye Semerci
state: Center
Study officials:
References: