Clinical trial NCT06163196: The Effect of Acupressure on Pain in Children With Thalassemia
Official title: The Effect Of Acupressure Application On Reducing Pain During Venipuncture İn Children Dıagnosed With Thalassemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: acupressure
thalassemia
child
pediatric nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, parallel , randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment of the child using the Wong Baker Facial Pain Rating scale
timeFrame: Measurements were taken from the scale just before blood was taken.
measure: Wong Baker Faces Pain Rating Scale
timeFrame: Measurements were taken just before blood was drawn and a scale was used immediately after blood was drawn.]
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yeni̇şehi̇r
Study officials:
affiliation: Mersin University
name: MELEK GULGUN ALTINTAS, Phd
role: PRINCIPAL_INVESTIGATOR
References: