NCT07400874

Brief Summary

This study aims to evaluate the effects of acupressure, music listening, and virtual reality applications, which appeal to the senses of touch, hearing, and sight during blood sampling, on pain, fear, and anxiety levels in children.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Blood CollectionFearPainAnxietyAcupressureVirtual realitylistening musicchild

Outcome Measures

Primary Outcomes (4)

  • 1. Patient Identification Form

    The form consists of a total of 7 questions covering the child's age, gender, previous hospital experience (if any), number of hospitalizations, whether their parents prepared them for blood tests beforehand, their experience with blood tests in the last six months, and their reactions to the blood test procedure.

    Baseline

  • Wong Baker Face Pain Scale

    Children between the ages of three and eight can express many pain areas and their severity. In this study, the Wong-Baker Pain Inventory will be used in combination with the Visual Analog Scale, since face scales are more appropriate. The Wong Baker Face Pain Scale was developed by Donna Wong and Connie Moran Baker in 1981. The scale is suitable for children between the ages of three and eighteen. The scale includes facial expressions that the child can enjoy and enjoy. For this reason, it has been stated that it gives more accurate results. The scale has scores of "0", "2", "4", "6", "8", and "10". A score of "0" indicates no pain and a score of "10" indicates the highest pain. This scale does not have a Cronbach's alpha score. It has been reported that reliability studies have not been conducted on such scales.

    Baseline and up to 4 weeks

  • 3. Child Fear Scale

    The Turkish validity of this scale, developed by McMurtry and colleagues, was done by Gerçeker and colleagues. The changes in the facial muscles of the frightened expression were drawn by a graphic artist from a photograph of a frightened face. It can be used by the parent, child or researcher to scale the child's fear. The scale, which has facial expressions scored from 0 to 4, is shown to the child. A score of 4 indicates that the child is very frightened, and a score of 0 indicates that the child is not frightened. It is accepted that a score of "0" indicates a neutral expression (no fear), a score of "1" indicates a very low level of fear, a score of "2" indicates a little fear, a score of "3" indicates a greater level of fear, and a score of 4 indicates that the level of fear is at the highest level. This scale can be used to measure fear before and during the procedure.

    Baseline and up to 4 weeks

  • 4. The Child Anxiety Scale-State (CAS-S)

    Developed by Ersig et al. in 2013, the Child Anxiety Scale-State measures situational anxiety in children aged 4-10 years. Its validity was established by Gerçeker et al. in 2017. The CAS-S (State) is designed as a thermometer. At the bottom is a bulb, and horizontal lines extend upwards. Each horizontal line represents a score, and the thermometer has 10 points. The bulb at the bottom represents 0 points, indicating no anxiety. As the lines rise, anxiety increases. The peak, worth 10 points, represents the highest level of anxiety.

    Baseline and up to 4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Routine clinical care will be applied to the control group. No action will be taken.

Experimental Group

EXPERIMENTAL

Before blood is drawn, the child will undergo acupressure, watch a video through virtual reality glasses, and listen to music through headphones.

Other: AcupressureOther: Listening MusicOther: Virtual Reality

Interventions

Acupressure will be administered by a researcher who has completed the Acupressure application course at Ankara Başkent Personal Training Institutions and received their certificate. To determine the child's ability to assess the scale, they will be asked, "Is 8 bigger than 4?". Before the acupressure application, the child's area will be prepared in the blood collection room. Hands will be washed and warmed by rubbing before the acupressure application. Pressure will be applied for 1.5 minutes to point 4 of the large intestine (LI4), located on the radial side of the 2nd metacarpal bone, at the junction of the 1st and 2nd metacarpal bones, on the back of the hand. Then, the blood collection nurse will begin the blood collection procedure from the same arm. Pressure will continue for another 1.5 minutes while the blood collection procedure continues. In total, pressure will be applied to point LI4 for 3 minutes: 1.5 minutes before and 1.5 minutes during the procedure.

Experimental Group

Before the procedure, children will be given brief and understandable information, and if possible, calming and age-appropriate music will be chosen according to their musical preferences. The music will start 1-2 minutes before the procedure begins and continue through headphones or speakers during blood collection to distract the child's attention from the needle; it will also be played for another 1-2 minutes afterward to help the child relax and complete the procedure as a positive experience. During this process, the children's pain, fear, and anxiety levels will be measured.

Experimental Group

In this study, children will be shown cartoons via virtual reality glasses during blood collection. For both boys and girls, the content options will be the 360-degree virtual reality cartoon "Ice Age," chosen by experts in child development and psychology to be age and gender-appropriate. The suitability of "Ice Age" for children was evaluated by five academics specializing in child health, and all experts deemed it appropriate. Children will begin watching the cartoon via VR approximately 3 minutes before blood collection and will continue watching until the procedure is complete.

Experimental Group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between 5-10 years old Being healthy (no chronic disease diagnosis) Both child and parent agree to participate in the study Being able to communicate in Turkish Taking a blood sample in a single session Having no visual, auditory, or speech impairments, Being open to communication Being accompanied by a parent

You may not qualify if:

  • Having an allergy to any substance Having a chronic illness (Type 1 diabetes, etc.) Having upper respiratory tract diseases such as asthma, rhinitis, pharyngitis Having an obstructive condition in the nasal passages for any reason Having vision or hearing loss Having any neuropathological problem Having complaints of vomiting, nausea, or pain Having recently used sedatives, anesthetics, or analgesics Having a chronic illness Having visual-auditory and speech impairments History of sedative, analgesic, or narcotic substance use within 24 hours prior to admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Oluc T, Sarialioglu A. The effect of a hand puppet-based therapeutic play for preschool children on the fear and pain associated with blood collection procedure. J Pediatr Nurs. 2023 Sep-Oct;72:e80-e86. doi: 10.1016/j.pedn.2023.06.012. Epub 2023 Jun 15.

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gamze AKAY, 1

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share