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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06163196
Other study ID # j94ghcf2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 4, 2022
Est. completion date June 4, 2022

Study information

Verified date December 2023
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized controlled trial evaluates the effect of acupressure on reducing the pain of blood collection in children with Thalassemia. The hypothesis of this study is that acupressure application reduces acute pain.


Description:

A total of 39 children with a diagnosis of Thalassemia were randomly assigned to the study and control groups. In the study group (n:19), blood pressure, pulse and oxygen saturation were measured, and the acupressure points determined (large intestine meridian 4. Point: LI 4, large intestine meridian 11. Point: LI 11, Heart Meridian 7. Point: HT 7 ) acupressure was applied for only one session by applying light pressure with the thumb of the practitioner's hand, in two directions as the right and left arms, for 2 minutes to each point for a total of 12 minutes. Blood was drawn immediately after the procedure. In order to evaluate the child's pain immediately after the blood collection procedure, the child was asked to mark the most appropriate face on the Wong Baker Faces Pain Rating Scale. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form. Placebo (sham) acupressure application is the pressure of the fingers on the non-meridian region without a specific acupressure point. The point used in our research is the point located in the middle of the third and fourth metacarpal bones on the back of the hand. The children in the placebo control group were only touched by the researcher without applying pressure and massage for one minute to the determined placebo point immediately after their physiological parameters were evaluated, and immediately after that, blood collection was performed. Immediately after blood collection, the child was asked to mark the most appropriate facial expression on the Wong Baker Faces Pain Rating Scale so that he or she could evaluate his pain. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date June 4, 2022
Est. primary completion date June 4, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Registered in the centers where the study will be carried out, - Able to communicate verbally - No developmental or sensory disabilities, - No mental illness - No opioid, narcotic analgesic or sedative use in the last 8 hours before the procedure, - No other chronic disease - One-time bloodletting - Children who agree to participate in the study. Exclusion Criteria: - Having pain before the blood draw procedure, - Not between the ages of 6-18, - Have developmental or sensory disabilities, - Having a mental illness - Using opioids, narcotic analgesics or sedatives in the last 8 hours before the procedure, - Having another chronic disease, - One-time blood sampling is not performed, - Fractures or signs of inflammation at acupressure application points

Study Design


Related Conditions & MeSH terms


Intervention

Other:
acupressure
Before the blood collection procedure, pressure will be applied to the acupressure points determined by the researcher for 2 minutes and then blood collection will be performed.

Locations

Country Name City State
Turkey Mersin University Mersin Yeni?sehi?r

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain assessment of the child using the Wong Baker Facial Pain Rating scale The Wong Baker Facial Pain Rating Scale is rated from 0 to 10 (such as 0-2-4-6-8-10). "0" means no pain, and "10" means the most severe pain. This scale is used to diagnose pain in children ages 3-18. Measurements were taken from the scale just before blood was taken.
Primary Wong Baker Faces Pain Rating Scale It is applied by explaining to the child that each face belongs to a person, that there is a happy face that does not have any pain, and a sad face that feels a little or a lot of pain. The child is asked to choose the face that best expresses his or her feelings by giving an explanation for each face ("0": he is very happy because he has no pain, etc.). Measurements were taken just before blood was drawn and a scale was used immediately after blood was drawn.]
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