Effects of Liquid Hourglass and Spiky Ball on Pain, Fear, Anxiety and Emotional Manifestations

NCT06994637 | Completed

• 1 other identifier: HakkariU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of liquid hourglass and spiky ball applied during venous blood collection on pain, fear, anxiety and emotional indicators in children aged 4-6. Research Hypotheses H1: The mean pain scores of children in the liquid hourglass group are lower than the mean scores of children in the control group. H2: The mean fear scores of children in the liquid hourglass group are lower than the mean scores of children in the control group. H3: The mean anxiety scores of children in the liquid hourglass rod group are lower than the mean scores of children in the control group. H4: The mean emotional indicator scores of children in the liquid hourglass rod group are lower than the mean scores of children in the control group. H5: The mean pain scores of children in the spiky ball group are lower than the mean scores of children in the control group. H6: The mean fear scores of children in the spiky ball group are lower than the mean scores of children in the control group. H7: The mean anxiety scores of children in the spiky ball group are lower than the mean scores of children in the control group. H8: The mean emotional indicator scores of children in the spiky ball group are lower than the mean scores of children in the control group.

Conditions

Pain; Anxiety and Fear; Procedural Anxiety; Procedural Pain

Outcome Measures

Primary Outcomes (1)

• Pain During Venous Blood Collection in Children

  "Pain is a specific unpleasant sensation originating from any part of the body, encompassing all past experiences of a person, whether or not due to an organic cause."

  "2 months"

Other Outcomes (3)

• Fear During Venous Blood Collection in Children

  "2 months"

• Anxiety During Venous Blood Collection in Children

  "2 months "

• Emotional Manifestation During Venous Blood Collection in Children

  "2 months "

Study Arms (3)

Liquid Hourglass

EXPERIMENTAL

Liquid Hourglass: The liquid hourglass to be used in the study is approximately 14 cm long and made of high-quality plastic material. It contains colored liquid gel. When the hourglass is turned, the colored liquid gel inside flows downwards in the form of bubbles, drop by drop. It is suitable for use by all age groups of children. The liquid hourglass method will be applied to the children in this group as a non-pharmacological application. Children will be given a liquid hourglass and during the blood collection process, the researcher or parent will turn it and watch the colored bubbles made by the liquid gel flow down by drop, and they will be allowed to take the liquid hourglass with their free hand if they wish. The liquid hourglass will be cleaned with alcohol after it is used on each child. The blood collection process will be performed by the nurse working in the blood collection unit.

Other: Liquid Hourglass

Spiky Ball

EXPERIMENTAL

Spiky Ball: The spiky ball to be used in the study is a ball made of sturdy environmentally friendly plastic, approximately 6 cm in size. This ball has a hard body with thorns on it and provides tactile stimulation by pricking the child's fingers. The pressure applied by the thorns on the balls to the hand can reduce pain, muscle tension and stress by stimulating the nerve endings more quickly. It is suitable for use by children over the age of two. The tactile stimulation on the spiky ball can distract the child during the blood collection process. The children in this group will be applied the spiky ball method as a non-pharmacological application. Children will be given a spiky ball and asked to hold the ball in the palm of the arm where the blood collection process is performed. The spiky ball will be cleaned with alcohol after it is used on each child. The blood collection process will be performed by the nurse working in the blood collection unit.

Other: Spiky Ball

Control Group

NO INTERVENTION

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. The blood collection process will be performed by the nurse working in the blood collection unit.

Interventions

Liquid Hourglass OTHER

The liquid hourglass to be used in the study is made of high-quality plastic material, approximately 14 cm long. It contains colored liquid gel. When the hourglass is turned, the colored liquid gel inside flows downwards in the form of bubbles, drop by drop. It is suitable for use by all age groups of children. The visual and moving nature of the liquid hourglass may distract the child during the blood collection process.

Liquid Hourglass

Spiky Ball OTHER

The spiky ball to be used in the study is a ball made of sturdy environmentally friendly plastic, approximately 6 cm in size. This ball has a hard body with thorns on it and provides tactile stimulation by pricking the child's fingers. The pressure applied by the thorns on the balls to the hand can reduce pain, muscle tension and stress by stimulating the nerve endings more quickly. It is suitable for use by children over the age of two. The tactile stimulation on the spiky ball can distract the child during the blood collection process.

Spiky Ball

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 and parent must agree to participate in the research
• The child and parent must be able to speak Turkish

You may not qualify if:

• The child is not in the appropriate age range
• The child is in pain
• The child has a mental or auditory disability
• The child is unconscious
• The child and parent do not agree to participate in the study

Sponsors & Collaborators

• Hakkari Universitesi: lead

Study Sites (1)

Hakkari University

Hakkâri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To minimize potential bias during data collection, all assessments were conducted by an independent nurse who was not involved in the study. However, due to the visible and interactive nature of the interventions, blinding of participants, parents, and the nurse performing the procedure was not feasible. To prevent allocation bias, the randomization table was created by an independent statistician.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Intervention Group-Liquid Hourglass Group: The liquid hourglass method will be applied to the children in this group as a non-pharmacological application. Children will be given a liquid hourglass and during the blood collection process, the researcher or parent will turn it and watch the colored bubbles made by the liquid gel flow down by drop, and they will be allowed to take the liquid hourglass with their free hand if they wish. Intervention Group-Spiky Ball Group: The children in this group will be applied the spiky ball method as a non-pharmacological application. Children will be given a spiky ball and asked to hold the ball in the palm of the arm where the blood collection process is performed. 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 29, 2025
• Study Start: October 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)