Blood Sampling, Children, Fear, Pain
Conditions
Keywords
pain, fear, blood sampling, children
Brief summary
Blood sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. ShotBlocker and finger puppets are one of these techniques. The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sampling in the pediatric blood sampling unit.
Interventions
Distraction techniques such as Shotblocker, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Shotblocker group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study is being conducted using a parallel group randomized controlled trial design.
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Being between 5 and 10 years old * Not having chronic pain * Not using sedative/anticonvulsant/analgesic medication * Not having a mental or neurological disability * Blood collection should be performed by the same nurse
Exclusion criteria
* Having chronic pain * Using sedative/anticonvulsant/analgesic medication * Having a mental or neurological disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | Time frame is up to 12 moths. From October 01 2025 to October 01 2026. | The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sapmling in the pediatric blood collection unit. On the child fear scale, "0" indicates no fear; "4" indicates the highest level of fear. It consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain. Data collection takes no more than 10 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Randomization | Time frame is up to 15 minutes. | Randomization in the study has been done with using a computer program (https://www.randomizer.org). To determine which children would be in the intervention and control groups, children with numbers from 1 to 90 were entered into the computer program without repetition. To avoid bias in randomisation and to increase reliability, the assignment to the intervention and control groups was made by an independent statistician. All blood collection procedures will be performed by the same nurse. A nurse with a four-year nursing diploma working in the same blood collection unit will serve as an independent observer. The observer will evaluate the children in the experimental and control groups. |
| Data Collection Tools | Time frame is up to 15 minutes. | In data collection, interview and observation form created by researchers (child's age, gender, previous blood sampling experience, etc.), the Children's Fear Scale, and the Wong-Baker FACES Pain Rating Scale will be used for all groups. |
| Children's Fear Scale (CFS) | Time frame is up to 10 minutes. | This scale is rating from 0 to 4 with five drawn facial expressions representing a range from a neutral expression (0 = no fear) to a frightened face (4 = extreme fear). It may be used by parents and researchers before and during the procedure for children. |
| Wong-Baker FACES (WB-FACES) Pain Rating Scale | Time frame is up to 10 minutes. | This scale is used to rate pain in children aged 3 years and older. The scale consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain. Children are asked to select the facial expression that most accurately reflects the intensity of their pain, and then a score is assigned. |
| ShotBlocker | Time frame is up to 5 minutes. | ShotBlocker was used on children in the ShotBlocker group during blood sampling. ShotBlocker device (Bionix LLC, Maumee, Ohio, USA) is a drug-free, flexible, and U-shaped, non-invasive plastic apparatus with small protrusions. It is placed directly on the skin and has a slit in the middle for inserting the needle. It is pressed firmly onto the skin, and the blunt contact points provide painless physical stimulation. This blocks the perception of pain caused by needle insertion, which is consistent with the "gate control" theory of pain. |
| Finger Puppet | Time frame is up to 5 minutes. | Finger puppets were used on children in the finger puppet group during blood sampling. Finger puppets consist of plush toys featuring various animal figures that can be worn on adults' fingers. The researcher put on the finger puppet chosen by the child and spoke to the child by imitating animal sounds. After the intervention, finger puppets were given as gifts to the children who wanted them. |
| Data Collection | Time frame is up to 15 minutes. | The same nurse will perform the blood collection procedure on the children. A nurse with a four-year nursing degree working in the same blood collection unit will become an independent observer. The observer will assess the pain and fears of the children in the experimental and control groups using scales. The researcher will give the interview and observation form to the parent to fill out before the blood drawing. The child's level of fear regarding the procedure will be recorded using the CFS by asking separate questions to the child, parent, and observer before the procedure. The child's fear of the procedure and pain will be separately assessed and recorded by the child, parent, and observer after the procedure. The child, parent, and observer independently and simultaneously evaluated the scales will be used. The ShotBlocker and finger puppet will be administered to the children in the experimental groups by the same researcher. |
Countries
Turkey (Türkiye)
Outcome results
None listed