The Effect of Two Different Types of Hourglasses on Pain, Fear, and Anxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-10
SponsorHakkari Universitesi
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Liquid Gel-Based Hourglass
Other interventionThe 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
Other interventionThe 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Liquid Gel-Based HourglassExperimental treatment 1 intervention
Group B: Sand-Based HourglassExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
"1 year"2
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.
Time frame
"1 year"3
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.
Time frame
"1 year"Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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