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

The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety During Blood Collection in Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Anxiety; Fear; Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Other: Liquid Gel-Based Hourglass; Other: Sand-Based Hourglass

Detailed Description

Pain, fear, and anxiety experienced by children during medical procedures constitute a significant clinical and psychosocial concern. Venipuncture, particularly common among invasive procedures performed on children aged 5-10 years, can trigger strong emotional reactions in this age group. These reactions may negatively affect not only the procedure itself but also children's long-term trust in the healthcare system, treatment adherence, and tolerance of future procedures.

Failure to effectively manage the anxiety and fear that arise during invasive procedures in children may lead to movement, increased pain, delays in the procedure, and challenges in terms of staff safety. Moreover, children who experience high levels of fear and anxiety may later avoid similar procedures, which poses a serious risk for access to healthcare services and adherence to treatment. Therefore, identifying and optimizing non-pharmacological, low-cost, and feasible methods used during invasive procedures is of utmost importance.

One of the non-pharmacological strategies used to reduce pain, fear, and anxiety during invasive procedures in children is active and passive distraction. Active distraction methods involve the child's engagement in surrounding activities such as playing games, crafts and coloring, tablet/computer games, role-play, and storytelling. These methods require the child to use hand-eye coordination, cognitive skills, or imagination and often reduce pain and anxiety more effectively. Passive distraction methods rely on the child's observation or listening to an activity and include watching videos/cartoons, listening to music or stories, and observing visual toys (e.g., sand timers). These methods provide visual and auditory stimuli that help redirect attention away from painful cues and are generally easy to implement. In summary, while active methods involve the child's active participation in the process, passive methods rely solely on focusing on an external stimulus. Studies in the literature indicate that both methods play an important role in reducing pain, fear, and anxiety experienced by children during invasive procedures.

Among passive distraction methods, sand timers are used as visual toys. The reason for selecting two different types of sand timers for children is the potential for their visual and cognitive stimulus properties to influence levels of pain, fear, and anxiety differently. The traditional sand-based timer offers a simple visual stimulus by displaying the natural flow of sand and is familiar and calming for most children. In contrast, liquid gel-based timers provide a more dynamic and attention-grabbing stimulus through colorful liquid and varying flow speeds. These differing characteristics may influence how effectively children's attention can be diverted from painful cues during venipuncture. However, the literature on the effectiveness of visual distractors such as sand timers remains limited. Sand timers are simple, portable, and low-cost tools to capture children's attention, but differences between sand-based (traditional) and liquid gel-based versions-such as visual effects, flow speed, and color variations-have not been fully explored regarding their impact on pain, fear, and anxiety. This gap creates uncertainty about which type is more effective in clinical practice.

Systematically evaluating the effects of liquid gel-based and traditional sand timers on children's experience during invasive procedures may provide valuable evidence for nursing practice and pediatric care protocols. If simple and low-cost tools such as sand timers can reduce pain, fear, and anxiety during venipuncture, their widespread use may enhance children's procedural experiences and improve their cooperation and morale. Lower levels of pain and fear may help children move less during the procedure, increasing the safety of both the child and healthcare staff and supporting their compliance with future procedures. Furthermore, compared with medication- or device-based interventions, sand timers offer economic and logistical advantages; their ease of application in clinical settings and minimal training requirements make them highly feasible for practice.

This study aims to fill this gap in the literature, provide concrete recommendations regarding non-pharmacological support strategies for children during venipuncture, and contribute to improving children's healthcare experiences. It is also expected to support the efficient use of pediatric nurses' time and enhance the quality of care.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid Gel-Based Hourglass; 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; 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.
Experimental: Sand-Based Hourglass; 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; 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.
No Intervention: Control Group; Children in this group will not receive any pharmacological or non-pharmacological intervention other than routine blood collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"

Collaborators and Investigators

• Sponsor: Hakkari Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Pain; Anxiety Disorders
• Other Study ID Numbers: HakkariUO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No