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PainNCT06994637

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

A study testing Liquid Hourglass and Spiky Ball in people with Pain and Anxiety and Fear, run by Hakkari Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Anxiety and Fear, Procedural Anxiety
What is being tested?
Liquid Hourglass and Spiky Ball
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2025to 30 Nov 2025
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 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hakkari University

    Hakkari

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Liquid Hourglass and Spiky Ball on Pain, Fear, Anxiety and Emotional Manifestations During Venous Blood Collection in Children: A Randomized Controlled Study

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.

Read more

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.

Read the detailed description

The most common invasive procedures that children encounter, such as blood collection, peripheral vascular access, injection, and lumbar puncture, are among the painful and disturbing procedures. These procedures can cause pain, fear, and anxiety in children. Especially between the ages of three and six, children have magical thoughts about the disease due to their immature abstract thinking and cause-effect skills, and may perceive pain, fear, and painful situations as punishment for not listening to their parents. Considering these developmental characteristics of preschool children, it is important to make the process less stressful with appropriate support and guidance during painful medical procedures and to better respond to children's emotional needs. In particular, blood collection is among the medical interventions in which these emotional reactions are experienced most intensely. Unmanaged pain, fear, and anxiety related to these procedures in children can cause many physiological and psychological consequences. These negative experiences can lead to maladaptive pain reactions, poor cognitive and motor development, needle phobia, avoidance of healthcare personnel and services, and long-term traumatic memories that can continue throughout adulthood. For these reasons, managing pain, anxiety, and fear in children is very important. Management of pain, anxiety, and fear requires a multidisciplinary team to work collaboratively. The nurse has an indispensable role in this team. The American Association of Pain Management Nursing reported that nurses are responsible for providing pain control using pharmacological and non-pharmacological methods before, during, and after interventions in individuals exposed to painful procedures. Non-pharmacological methods that can be used in the effective management of pain are among the independent care roles of nurses. Non-pharmacological methods are classified as physical, cognitive-behavioral, and other supportive methods. Distraction intervention, one of the cognitive-behavioral methods, aims to alleviate pain, stress, and anxiety during painful procedures in pediatric patients by directing attention from a painful stimulus to an interesting object or a non-threatening, pleasant stimulus. Among these, applications such as watching cartoons or videos, distraction cards, virtual reality, blowing balloons and coughing, listening to music, playing games, and using a kaleidoscope support the reduction of pain, fear, and anxiety by diverting attention from painful stimuli. Among the physical methods, Buzzy, ShotBlocker, hot or cold applications, massage, providing stimulation to the skin, and giving a ball to the palm are the methods used to reduce pain, anxiety, and fear. Nowadays, in addition to the products available on the market to reduce pain and anxiety, there is an increasing interest in innovative methods. Based on this, in the scope of the research we planned, unlike previous studies, we wanted to examine the liquid hourglass and spiky ball.

One of the attention-grabbing methods used for pain, fear and anxiety management in medical procedures in children may be the liquid hourglass method. It is a cheap, easy, effective, side-effect-free and safe intervention to help children cope. It is stated that the liquid moving hourglass can be successful in distracting pediatric patients because the colored bubbles provide a calming and visually stimulating experience while floating and descending. Studies have shown that visual and moving toys reduce children's pain, fear and anxiety levels during the blood collection procedure. When the literature is examined, no study has been found examining the effect of liquid hourglass applied during blood collection on pain, fear and anxiety in children. Distraction methods are supported by various tactile stimulation tools. Tactile stimulation distracts the child's attention and focuses his/her attention away from painful sensations and on tactile stimulation, thus reducing the sensation of pain. Tactile stimulation is frequently used for the management of pain in invasive procedures. Tactile stimulation is an intervention that has the potential to block pain transmission. According to the gate control theory, tactile stimulation produced by physical interventions closes the pain gate in the spinal cord and helps reduce the level of pain by increasing the activation of somatosensory sensory areas. In addition, since the stimuli cross the spinal cord, the tactile stimulus can be applied directly to the painful area, proximal or distal to that area, and symmetrically opposite (contralateral) to the painful area. The spiky ball application is designed as a plastic apparatus with a hard body with thorny protrusions that generate tactile stimulation from the palm. The pressure applied by the thorns on the balls to the hand stimulates the nerve endings more quickly, which can reduce the pain, muscle tension, and stress experienced by children during invasive procedures. It has been determined that there are limited studies in the literature using a spiky ball as a tactile stimulus from the palm to reduce pain, fear and anxiety during venous blood sampling.

Since there are no studies examining the effect of using liquid hourglass on reducing pain, fear and anxiety during blood collection in children and the use of spiky balls is limited, it is thought that the study will add new information to the literature and contribute to reducing the problems caused by painful applications for children, their families and pediatric nurses with the use of new methods.

Being tested
Liquid Hourglass, Spiky Ball
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 HourglassOther

    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.

  • Spiky BallOther

    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.

Study groups in NCT06994637
Study groupRoleWhat they receive
Liquid HourglassExperimentalLiquid 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.
Receives: Other: Liquid Hourglass
Spiky BallExperimentalSpiky 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.
Receives: Other: Spiky Ball
Control GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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."

    Measured: "2 months"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start1 Oct 2025
  3. Primary completion30 Nov 2025
  4. Study completion30 Nov 2025

Resources

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
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06994637
Sponsor's protocol ID
HakkariU
Status last verified
Feb 2026
First submitted
26 Apr 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Liquid Hourglass and Spiky Ball in people with Pain and Anxiety 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 3 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 11 Feb 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 (time frame: "2 months"). 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 11 Feb 2026.

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