Effects of Rain Stick and Musical Egg on Pain, Fear and Anxiety

NCT06983093 | Not Yet Recruiting

• 1 other identifier: HakkariOU
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research will be conducted in a pre-test-post-test parallel group randomized controlled experimental study model to determine the effects of rain stick and musical egg applied during blood collection on pain, fear and anxiety in children aged 4-6. Research Hypotheses H1: The mean pain scores of the children in the rain stick group are lower than the mean scores of the children in the control group. H2: The mean fear scores of the children in the rain stick group are lower than the mean scores of the children in the control group. H3: The mean anxiety scores of the children in the rain stick group are lower than the mean scores of the children in the control group. H4: The mean pain scores of the children in the musical egg group are lower than the mean scores of the children in the control group. H5: The mean fear scores of the children in the musical egg group are lower than the mean scores of the children in the control group. H6: The mean anxiety scores of the children in the musical egg group are lower than the mean scores of the children in the control group.

Conditions

Procedural Pain; Procedural Anxiety; Fear Needles

Outcome Measures

Primary Outcomes (3)

• Pain During Blood Collection Procedure in Children

  It is an unpleasant, emotional and sensory feeling that originates from any part of the body, is accompanied by real or potential tissue damage, and encompasses all past experiences of the patient.

  "1 year"

• Fear During Blood Collection Procedure in Children

  It is a vital reaction that occurs as a stimulus response as a result of a specific pain or an event perceived as a threat.

  "1 year"

• Anxiety During Blood Collection Procedure in Children

  It is a psychiatric disorder that causes intense anxiety and worry about possible future threats that are perceived but not present.

  "1 year"

Study Arms (3)

Rainstick Group

EXPERIMENTAL

Intervention Group-Rainstick Group: The rainstick method will be used as a non-pharmacological application for children in this group. The rainstick will be given to the children and during the blood collection process, the researcher or parent will turn it up and down and watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand. The rainstick will be cleaned with alcohol after being used on each child. The blood collection process will be performed by the nurse working in the blood collection unit.

Other: Rain Stick

Musical Egg Group

EXPERIMENTAL

Intervention Group-Musical Egg Group: The musical egg method will be used as a non-pharmacological application for the children in this group. The children will be given a musical egg and during the blood collection process, the researcher or parent will turn it up and down and watch the sounds and movements and if they want, they will be allowed to take the toy with their free hand. The musical egg will be cleaned with alcohol after it is used on each child. The blood collection process will be done by the nurse working in the blood collection unit.

Other: Musical Egg

Control Group

NO INTERVENTION

The child will be taken to the blood collection room after being informed that the mother or father will be with him/her during the procedure. The child will be seated in the intervention chair. No pharmacological or non-pharmacological method will be applied to the children in this group other than routine blood collection. The blood collection will be performed by the nurse working in the blood collection unit.

Interventions

Rain Stick OTHER

The rain stick to be used in the study is a toy made of wood, ranging in length from 20 to 120 cm. It is also a very entertaining musical instrument that imitates the sound of real rain. It is suitable for use by children aged 4 to 6. It has spiral shapes and colorful beads inside. When the rain stick is turned up and down, it produces a perfect rain sound that drizzles and patters. It is also known as a rain sound stick. The visual and auditory nature of the rain stick can distract the child during the blood collection process.

Rainstick Group

Musical Egg OTHER

The musical egg to be used in the study is a toy made of wood, approximately 6.5-7 cm in size. These wooden shaker eggs are a fun and interesting musical instrument. It is suitable for use by children aged 4-6. It is filled with iron sand and when shaken, it makes a clear sound and adds a unique rhythm to the music. This egg imitates the sound of maracas when shaken. Maracas are a musical instrument that makes a sound when shaken thanks to the parts in its hollow body. It is also known as musical eggs, egg shakers, musical egg maracas, Easter egg percussion instruments. The visual and auditory nature of the musical egg can distract the child during the blood collection process.

Musical Egg Group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be between 4-6 years old
• The child must not have acute pain
• The child must not have mental or auditory disabilities
• The child must not have confusion
• The child and parent must agree to participate in the study

You may not qualify if:

• The child must be under 4 years old and over 6 years old
• The child's body temperature must be 38°C or above
• The child must have used an analgesic medication in the last 24 hours before the application

Sponsors & Collaborators

• Hakkari Universitesi: lead

MeSH Terms

Conditions

Pain, Procedural; Iatrophobia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In order to prevent bias, support will be obtained from an independent statistician. In addition, data will be collected by a nurse who does not know the groups not included in the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Intervention Group-Rainstick Group: The rainstick method will be used as a non-pharmacological application for the children in this group. The rainstick will be given to the children and during the blood collection process, the researcher or parent will turn it up and down to watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand. Intervention Group-Musical Egg Group: The musical egg method will be used as a non-pharmacological application for the children in this group. The musical egg will be given to the children and during the blood collection process, the researcher or parent will turn it up and down to watch the sounds and movements and if they wish, they will be allowed to take the toy with their free hand. Control Group: The child will be seated in the intervention chair. No pharmacological or non-pharmacological method will be applied to the children in this group other than the routine blood collection process.

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 21, 2025
• Study Start: December 31, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share