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Completed

NCT Number: NCT05828264

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

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.

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Key information

Conditions

Pain, Acute Acute Pain Anxiety Disorders Anxiety and Fear Behavior Child Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quantum Signs and Symptoms Venipuncture Site Reaction

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Remziye Semerci

Edirne, Center, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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'.

Primary outcomes

  1. 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.

  2. 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) .

  3. Child Anxiety Scale-State

    Time frame: One minute after the venipuncture procedure

    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".

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Koç University

Registry information

Official study title

The Effect of "Quantum-Touch" on Venipuncture Pain, Fear, and Anxiety in Children Aged 7-12 Years Old; Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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