The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety

NCT07312084 | Not Yet Recruiting

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

Brief Summary

This research will be conducted as a pre-test-post-test parallel group randomized controlled experimental study to determine the effects of two different types of hourglasses (liquid gel-based hourglass and sand-based hourglass) used for distraction during blood collection in children aged 5-10 years on pain, fear, and anxiety and the comparative effectiveness of these methods. Research Hypotheses H1: The mean pain, fear, and anxiety scores of children who used a liquid gel-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H2: The mean pain, fear, and anxiety scores of children who used a sand-based hourglass during blood collection were significantly lower than the mean scores of children in the control group. H3: The use of a liquid gel-based hourglass and a sand-based hourglass during blood collection had different effects on the mean pain, fear, and anxiety scores of children.

Conditions

Pain; Fear; Anxiety; Procedural Anxiety; Procedural Pain

Outcome Measures

Primary Outcomes (3)

• Pain During Venous Blood Collection in Children (Wong-Baker Facial Pain Scale)

  "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." The aim of the scale is to determine the level of pain based on numerical values corresponding to target facial expressions. Numerical values between 0 and 10 are used. A value of 0 indicates no pain, while a value of 10 indicates severe pain.

  "1 year"

• Fear During Venous Blood Collection in Children (Child Fear Scale)

  "It is a vital response that occurs as a response to a stimulus that is perceived as a specific pain or threat." The scale was developed to determine the level of fear in children aged 4-10 years. The scale uses facial expressions and is scored on a scale of "0-4". A score of "0" indicates no fear, while a score of "4" indicates excessive fear.

  "1 year"

• Anxiety During Venous Blood Collection in Children (Child Anxiety Scale - State)

  "It is a common psychological disorder that causes a person to have excessive and uncontrollable reactions to emotions such as worry, anxiety and fear." The CAS-D scale is shaped like a thermometer with a lightbulb at the bottom and horizontal lines at intervals going upwards. To measure CAS-D, the child is asked to indicate what they are feeling "right now." The scale is scored from 0 to 10. Children are asked to indicate their feelings of anxiety and nervousness from the bottom of the thermometer upwards (from least to most). Before using the scale, the child's sequencing skills are assessed. After being asked to count to ten, they are asked questions about which of two numbers is larger or smaller. Children who cannot follow the instructions or answer these questions are excluded from the scale.

  "1 year"

Study Arms (3)

Liquid Gel-Based Hourglass

EXPERIMENTAL

The liquid gel-based hourglass used in the study is approximately 13-14 cm long and made of high-quality plastic. It contains a highly viscous colored gel, which flows slowly and regularly in a drop-like pattern. These hourglasses are used during interventions not to measure time but to increase visual focus, distract attention, and provide a calming effect.

Other: Liquid Gel-Based Hourglass

Sand-Based Hourglass

EXPERIMENTAL

The sand-based hourglass used in the study is approximately 8.5 cm long and made of durable plastic and glass. It contains colored, fine-grained, dry sand. It's a classic mechanism that relies on the fine-grained sand flowing from the upper chamber to the lower chamber under the influence of gravity. This type of hourglass is used as a helpful tool to distract children and reduce procedural anxiety during the intervention.

Other: Sand-Based Hourglass

Control Group

NO INTERVENTION

Children in this group will not receive any pharmacological or non-pharmacological intervention other than routine blood collection.

Interventions

Liquid Gel-Based Hourglass OTHER

The liquid gel-based hourglass used in the study is approximately 13-14 cm long and made of high-quality plastic. It contains a highly viscous colored gel, which flows slowly and regularly in a drop-like pattern. These hourglasses are used during interventions not to measure time but to increase visual focus, distract attention, and provide a calming effect.

Liquid Gel-Based Hourglass

Sand-Based Hourglass OTHER

The sand-based hourglass used in the study is approximately 8.5 cm long and made of durable plastic and glass. It contains colored, fine-grained, dry sand. It's a classic mechanism that relies on the fine-grained sand flowing from the upper chamber to the lower chamber under the influence of gravity. This type of hourglass is also used as a helpful tool to distract children and reduce procedural anxiety during the intervention.

Sand-Based Hourglass

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being between 5 and 10 years old,
• Agreeing to participate in the research by applying to the blood collection unit,
• Written consent being obtained from the parent,
• Physical and mental development being appropriate for the age.

You may not qualify if:

• Being outside the specified age range,
• Having a serious chronic disease or hematological disorder,
• Having developed serious trauma or intense anxiety due to a previous blood draw,
• Refusal to participate in the study or failure to obtain parental consent,
• Psychiatric or neurological disorders that may affect the implementation of the study.

Sponsors & Collaborators

• Hakkari Universitesi: lead

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: 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: Associate Professor

Model Details: Liquid Gel-Based Hourglass Group: Children in this group will be administered a liquid gel-based hourglass as a non-pharmacological method. During blood collection, the hourglass will be kept in the children's view and, accompanied by the researcher or parent, will be turned, and the children will observe the flow of moving bubbles in the hourglass. Sand-Based Hourglass Group: Children in this group will be administered a conventional sand-based hourglass as a non-pharmacological method. During blood collection, the hourglass will be kept in the children's view and, accompanied by the researcher or parent, will be turned, and the children will observe the flow of sand grains. Control Group: Children in this group will not receive any pharmacological or non-pharmacological interventions other than routine blood collection.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 31, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12