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Fear of PainNCT06443437

Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy

A study testing bee-buzzy vibrating cold application marionette doll and Rotuine care in people with Fear of Pain, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. Read more about this study

Who is it for?
Ages 3 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Fear of Pain
What is being tested?
bee-buzzy vibrating cold application marionette doll and Rotuine care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
31 May 2024to 30 Jun 2024
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 3 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • children and parents who agreed to participate in the study
  • children had successful phlebotomy in the first attempt.

Who cannot join

  • Children who are having a chronic disease
  • Mental disability or mental retardation
  • Taking analgesics in the last 24 hours
  • Undergone a surgical procedure,
  • Not having a successful phlebotomy on the first attempt,
  • The child and his/her family not being willing to participate in the study.

Trial locations and contacts

1 site in 1 country.

Shimaa H Khalf allah, post doctor contact

01097248758 ext. 01124969115

shimaa_hassan@aun.edu.eg

Atyat M Hassan, post doctor contact

Egypt1 site, 1 recruiting

  • Assiut university children hospital

    Asyut

    shimaa h khalf allah

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Bee-buzzy Vibrating Cold Application and Marionette Doll on Pain and Fear During Phlebotomy Among Preschool Children: A Randomized Controlled Study

Non-pharmacological methods are often used as a creative strategy to reduce pain and fear in children during a painful procedure such as phlebotomy. In this context, external vibratory cold application and a marionette doll are a commonly used as non-pharmacological distraction method to reduce pain and fear. In the literature, there are studies with cold application, vibrating devices and a marionette doll in bee appearance therefor this study is aimed to evaluate the effect of bee-buzzy vibrating cold application and marionette doll on pain and fear during phlebotomy among preschool children.

Read the detailed description

Pain is one of the negative experiences faced in pediatric patients due to various medical interventions and often causes fear and anxiety. Pain perception is affected by the child's age, cognitive development, communication skills, previous pain experiences, and pain beliefs. Severe and long-term pain resulting from interventions can cause behavioral and physiological problems. In this period, if the pain is not alleviated or eliminated with appropriate interventions, it may cause neurological and behavioral disorders in the future. Nurses are responsible for minimizing the pain felt by children exposed to painful interventions and helping them cope with it .

Conditions
Fear of Pain
Being tested
bee-buzzy vibrating cold application marionette doll, Rotuine care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bee-buzzy vibrating cold application marionette dollOther

    Also called marionette doll

    • Bee-buzzy will be attached to the arm of the preschool child (who is included in the bee-buzzy group) by the researchers, where the phlebotomy will be performed on the child. It reduces pain through its cold wings and vibration. It helps to distract attention during phlebotomy and reduces the feeling of pain and fear. Bee-buzzy will be tied 5 cm above the area from which blood will be drawn, and after waiting for 15 seconds, the nurse will perform a phlebotomy.
    • A marionette doll group; while the nurse is going to perform the phlebotomy operation on the preschool child, one of the researchers will try to distract the child by paly with marionette doll. The researchers will receive training in play therapy

  • Rotuine careOther

    children in control group will receive routine hospital are

Study groups in NCT06443437
Study groupRoleWhat they receive
study group 1Experimentalchildren who will receive bee-buzzy vibrating cold application
Receives: Other: bee-buzzy vibrating cold application marionette doll
study group 2Active comparatorchildren who will receive marionette doll
Receives: Other: bee-buzzy vibrating cold application marionette doll
control groupOtherchildren who will receive routine care
Receives: Other: Rotuine care

What is being measured

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

  1. child pain

    Facial expression rating scale (Wong-Baker Faces Pain Rating Scale). The Facial Expression Rating Scale includes 6 facial expressions and is a scale that provides a rating between 0 and 10 (Conlon, 2009; Huguet et al., 2010). Facial expressions range from"0" a smiling "brutal" face, 1-2 "It hurts a little", 3-4 "It hurts a little more", 5-6 "It hurts even more", 7-8 "It hurts a lot", and 9-10 "It hurts worst". This scale does not require words or numerical values and is a reliable and valid measurement tool in the assessment of acute pain. With this scale, the child's pain will be evaluated and recorded by both the nurse who will perform the phlebotomy and the parent.

    Measured: during phlebotomy

Secondary outcomes (1)

  1. child fear

    The "Children's Fear Scale" by McMurtry et al. (2011). This scale includes 5 different facial expressions. This scale is scored between 0 and 4 and it is stated to be a reliable and valid measurement tool in the evaluation of fear (McMurtry et al., 2011). The permission to use the scale was obtained by Binay and Bal Yılmaz (2019), and Turkish validity and reliability studies were conducted (Binay \& Bal Yılmaz, 2019; Binay \& Bal Yilmaz, 2022).

    Measured: during phlebotomy

Timeline

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

  1. First posted5 Jun 2024
  2. Study start31 May 2024
  3. Primary completion15 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443437
Sponsor's protocol ID
bee-buzzy&marionette doll
Status last verified
Jun 2024
First submitted
30 May 2024
Last updated
6 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yildirim BG, Gerceker GO. The Effect of Virtual Reality and Buzzy on First Insertion Success, Procedure-Related Fear, Anxiety, and Pain in Children during Intravenous Insertion in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2023 Jan;49(1):62-74. doi: 10.1016/j.jen.2022.09.018. Epub 2022 Nov 12.

    PubMed 36376127

  • Wang Y, Guo L, Xiong X. Effects of Virtual Reality-Based Distraction of Pain, Fear, and Anxiety During Needle-Related Procedures in Children and Adolescents. Front Psychol. 2022 Apr 19;13:842847. doi: 10.3389/fpsyg.2022.842847. eCollection 2022.

    PubMed 35519646

  • Ugucu G, Akdeniz Uysal D, Guzel Polat O, Artuvan Z, Polat Kulcu D, Aksu D, Gulgun Altintas M, Cetin H, Orekici Temel G. Effects of cartoon watching and bubble-blowing during venipuncture on pain, fear, and anxiety in children aged 6-8 years: A randomized experimental study. J Pediatr Nurs. 2022 Jul-Aug;65:e107-e114. doi: 10.1016/j.pedn.2022.03.016. Epub 2022 Apr 8.

    PubMed 35410736

  • Turgut MA, Turkmen AS. The effect of lighted toy on reducing pain and fear during blood collection in children between 3 and 6 years: A randomized control trial. J Pediatr Nurs. 2023 May-Jun;70:111-116. doi: 10.1016/j.pedn.2023.02.009. Epub 2023 Mar 9.

    PubMed 36905910

  • McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

    PubMed 21806301

  • Kuo HC, Pan HH, Creedy DK, Tsao Y. Distraction-Based Interventions for Children Undergoing Venipuncture Procedures: A Randomized Controlled Study. Clin Nurs Res. 2018 May;27(4):467-482. doi: 10.1177/1054773816686262. Epub 2016 Dec 30.

    PubMed 28038497

Questions about this trial

What is this clinical trial studying?

A study testing bee-buzzy vibrating cold application marionette doll and Rotuine care in people with Fear of Pain, run by Assiut University at 1 site in Egypt.

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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jun 2024. 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 Egypt. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shimaa H Khalf allah, post doctor (01097248758 ext. 01124969115, shimaa_hassan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

child pain (time frame: during phlebotomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443437, which also lists 6 linked publications.

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 6 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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