Usefulness of Preparation for Patients Receiving Medical Treatment with Needles

JRCT ID: jRCT1060240033

Registered date:14/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: No target disease, as this study does not focus on a specific disease
• Date of first enrollment: 14/07/2024
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Patients in the study will be assigned to the intervention group with prepalpation before blood collection and to the control group without prepalpation, separated by the study period. Accompanying parents and health care providers will not be included in the allocation.
The study period will consist of alternating blocks of measurements for the intervention group and the control group. Each block will last two weeks, and eligible patients who indicate their willingness to participate in the study during the morning pediatric visit during the study period will be asked to participate in the study. Implementation of the control group will be stopped when the number of participants in the control group exceeds 50. The intervention group will also be stopped when the number of participants in the intervention group exceeds 50.

Outcome(s)

• Primary Outcome: Changes in stress related to blood collection in affected children before and after blood collection.

Secondary Outcome

Relationship between age, gender, and stress related to blood collection in affected children.
Changes in heart rate of affected children before, after intervention, and after blood draw.
Changes in parents' perceived stress about blood collection for their affected children before and after blood collection.
Association between the Multidimensional Fear of Injection Scale and stress related to blood collection in affected children.
Evaluation of Parental Preparation.
Assessment of health care providers' prep.

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: <= 11age old
• Gender: Both

Include criteria

Patient Affected Childre
Patients who will have their blood drawn at the Department of Pediatrics, Tottori University Hospital.
Patients who are at least 4 years old and less than 11 years old at the time of consent.
Who are able to view the prepration video.
Have not participated in this study in the past.
Parents or guardians of the affected children
Those who will accompany the child who meets the above selection criteria for blood sampling.
Health Care Worker
Health care providers who will collect blood samples from children who meet the above selection criteria.

Exclude criteria

Patient Affected Childre
Persons deemed inappropriate as research subjects by the principal investigatorGuardian of the affected child.
Parents or guardians of the affected children
Persons deemed inappropriate as research subjects by the principal investigator.
Health Care Worker
Persons deemed inappropriate as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Yuko Ida