The Effect of Acupressure on Pain in Children With Thalassemia

NCT06163196 | Completed

• 1 other identifier: j94ghcf2
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

acupressure; thalassemia; child; pediatric nursing

Outcome Measures

Primary Outcomes (2)

• 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.]

Study Arms (2)

accupressure

EXPERIMENTAL

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

control

SHAM COMPARATOR

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

Interventions

acupressure OTHER

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.

accupressure; control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yeni̇şehi̇r, 33010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Thalassemia

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• MELEK GULGUN ALTINTAS, Phd

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Since there are 40 children with a diagnosis of Thalassemia in total, aged between 6-18 years, who applied to Mersin City Training and Research Hospital Pediatric Hematology Polyclinic and Daily Pediatric Service between 7 February and 4 June 2022, agreed to participate in the study, and gave permission from their parents, without sampling. 39 children participated. The acupressure group consisted of 19 children and the placebo group consisted of 20 children. During the procedure, children were taken into the room where blood collection took place, one by one, together with their parents. Thus, children and parents participating in the study were prevented from influencing each other. During the application and analysis processes of the research, the groups represented by the papers written "Group A" and "Group B" were blinded and hidden from the child who agreed to participate in the research, the parents, and the statistician who performed the analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: prospective, parallel , randomized controlled clinical trial

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: December 8, 2023
• Study Start: June 4, 2022
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)