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Completed

NCT Number: NCT05585840

The Effect of Biofeedback-Based Virtual Reality Game on Children

The needles of port catheters, which are often used in childhood cancer treatment, must be changed every 5-7 days, which causes pain, anxiety, and fear in children every 5-7 days In recent years, the usage of virtual reality has grown to distract children during port catheter needle insertion. But it's not always easy for children to switch their attention to something else. A good child distractor must be sensory-stimulating, developmentally appropriate, and highly interactive.

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Key information

Conditions

Pediatric Cancer Anxiety Disorders Mental Disorders Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koc University

Istanbul, Turkey (Türkiye)

About this study

Today, virtual reality applications have advanced, and software that provides biofeedback with breathing has improved engagement with the user. Our aim in this study is to examine the effect of biofeedback-based virtual reality games on pair, fear and anxiety levels during insertion of port needle insertion in children.

The randomized control trial design will be used, and The CONSORT list will be used to guide the research. This study will be conducted at the 62 pediatric oncology patients (31 experiment/ 31 control) aged 6-12 years. This study will be carry out in a university hospital in Istanbul, Turkey between January 2023, and June 2023. The research data will collect from the children's self-reports and parents through a survey form and scales. Children's pain will evaluate by the children and parent with Wong-Baker Faces Pain Rating Scale, child fear will evaluate by the children and parent with 'Child Fear Inventory', and child anxiety will evaluate by the children and parent with 'Child Anxiety Statement Scale'.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between the ages of 6-12,
  • Requires venous access
  • Diagnosed with childhood cancer,
  • Volunteers with at least one venous access experience.

Exclusion criteria

  • With neurodevelopmental delay,
  • Difficulty in verbal communication
  • Auditory or visual impairment
  • Those who have used analgesics in the last 24 hours and have a history of needle phobia.

Treatment and study plan

Biofeedback-based virtual reality game

Device

The application will be a biofeedback-based virtual reality game developed by the researchers in collaboration with engineering in line with the literature review.

Primary outcomes

  1. Wong-Baker Faces Pain Rating Scale

    Time frame: Evaluation will be done approximately 5 minutes after port catheter needle placement.

    Wong-Baker Faces Pain Rating Scale. It is used in the assessment of pain in children. The scale consists of six facial expressions. Facial expressions range from 0 points of "no pain-very happy" to 10 points of "unbearable pain-crying". It is commonly used in children aged 3-18. It has good validity and reliability for the measurement of pain severity and is psychometrically suitable and widely used in clinical practice.

  2. The Child Fear Scale (CFS)

    Time frame: It will be evaluated 5-minute before the insertion of port needle.

    The Child Fear Scale (CFS). It measures procedure-related fear in children. It consists of five sex-neutral faces; 0 (no fear) - 4 (extreme fear). It is based on the Faces Anxiety Scale. The FAS changed developmentally to the CFS. It can be used by the parents during the procedure for 5-10 years old children. Assessment of construct validity revealed high concurrent convergent validity with another self-report measure of fear and moderate discriminant validity with coping and distress behavior.

  3. The Child Fear Scale (CFS)

    Time frame: It will be evaluated 5-minute after the insertion of port needle.

    The Child Fear Scale (CFS). It measures procedure-related fear in children. It consists of five sex-neutral faces; 0 (no fear) - 4 (extreme fear). It is based on the Faces Anxiety Scale. The FAS changed developmentally to the CFS. It can be used by the parents during the procedure for 5-10 years old children. Assessment of construct validity revealed high concurrent convergent validity with another self-report measure of fear and moderate discriminant validity with coping and distress behavior.

  4. The Children's Anxiety Meter (CAM)

    Time frame: It will be evaluated 5-minute before the insertion of port needle.

    The Children's Anxiety Meter (CAM). It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.

  5. The Children's Anxiety Meter (CAM)

    Time frame: It will be evaluated 5-minute after the insertion of port needle.

    The Children's Anxiety Meter (CAM). It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

The Effect of Biofeedback-Based Virtual Reality Game on Pain, Fear and Anxiety Levels During Insertion of Port Needle in Children

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2022
Registry last updated
Mar 6, 2024

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

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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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