PainNCT07312084
The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety
A study testing Liquid Gel-Based Hourglass and Sand-Based Hourglass in people with Pain and Fear, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- What is being tested?
- Liquid Gel-Based Hourglass and Sand-Based Hourglass
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pain, Fear, Anxiety, Procedural Anxiety, Procedural Pain
- Being tested
- Liquid Gel-Based Hourglass, Sand-Based Hourglass
- Medical subject headings
- Pain, Anxiety Disorders, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Gel-Based HourglassOther
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.
Sand-Based HourglassOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: "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.
Measured: "1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 May 2026
- Primary completion1 May 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakkari Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Demir Kösem, Hakkari Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312084
- Sponsor's protocol ID
- HakkariUO
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety During Blood Collection in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07312084
- Acronym / sponsor ID
- HakkariUO
- Conditions
- Pain, Fear, Anxiety, Procedural Anxiety, Procedural Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hakkari UniversitesiUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liquid Gel-Based Hourglass | Experimental | Other: Liquid Gel-Based HourglassThe 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. |
| Sand-Based Hourglass | Experimental | Other: Sand-Based HourglassThe 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. |
| Control Group | No intervention | –Children in this group will not receive any pharmacological or non-pharmacological intervention other than routine blood collection. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Gel-Based HourglassThe 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 HourglassThe 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. | Other | Sand-Based Hourglass |
Primary outcome
Pain During Venous Blood Collection in Children (Wong-Baker Facial Pain Scale)
Time frame: "1 year"
"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.
Fear During Venous Blood Collection in Children (Child Fear Scale)
Time frame: "1 year"
"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.
Anxiety During Venous Blood Collection in Children (Child Anxiety Scale - State)
Time frame: "1 year"
"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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Gel-Based Hourglass and Sand-Based Hourglass in people with Pain and Fear, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Venous Blood Collection in Children (Wong-Baker Facial Pain Scale) (time frame: "1 year"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.