The Effect of Acupressure on Pain in Children With Thalassemia (acupressure)

The Effect Of Acupressure Application On Reducing Pain During Venipuncture İn Children Dıagnosed With Thalassemia.

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: acupressure

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yeni̇şehi̇r
    • Mersin, Yeni̇şehi̇r, Turkey, 33010
      • Mersin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: accupressure; 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.	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.
Sham Comparator: control; 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. Children in the placebo control group (n:20) were touched by the researcher for one minute without applying pressure or massage to the determined placebo point immediately after their physiological parameters were evaluated. 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 assess his pain. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.]

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Principal Investigator: MELEK GULGUN ALTINTAS, Phd, Mersin University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2022
• Primary Completion (Actual): June 4, 2022
• Study Completion (Actual): June 4, 2022

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: child; acupressure; thalassemia; pediatric nursing
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Thalassemia
• Other Study ID Numbers: j94ghcf2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No