The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children

Not Applicable

Completed

• Conditions: Pediatric Cancer; Nausea With Vomiting Chemotherapy-Induced
• Interventions: Behavioral: sea-band acupressure; Behavioral: manuel acupressure; Behavioral: placebo manuel acupressure; Behavioral: placebo sea-band

• Registration Number: NCT04651608
• Lead Sponsor: Akdeniz University

Brief Summary

This study is carried out to evaluate and compare the efficiency of acupressure practice applied with pressure or sea-band and their placebo on managing the acute nausea-vomiting symptoms developing due to chemotherapy in pediatric oncology patients.

Detailed Description

Every year children aged 0 to 19 years old are diagnosed with cancer around the world. For pediatric oncology patients, chemotherapy-related acute nausea and vomiting are among most common symptoms and has a bad influence on quality of life. When it cannot be prevented, it can cause serious medical problems. Continuous, repetitive and unavoidable vomiting affects patients' and their families' quality of life adversely, causing delay or even termination in chemotherapy treatment. It is a well-known fact that medical treatment is insufficient to control nausea and vomiting symptoms. Therefore, supportive care is needed besides medical treatment. One of the approaches mentioned is acupressure. Non-invasive stimulation of the P6 acupuncture point is a harmless and complementary approach to health. The point between flexor carpi radialis and palmaris longus, located at a three finger distance from the wrist crease, is named as "P6 Nei-Guan". This acupuncture point, placed on the pericardium channel, is generally used to harmonize stomach and relieve the vomiting. Acupressure is a way of stimulation applied on acupuncture points by finger, palm or acustimulation bands (sea-band, relief band) and can be used for children as well. Acupressure is defined as one of the complementary health approaches which nurses can apply. It is stated that this method, which is non-invasive, economical, easy to apply and reliable, has no side effect and patients can apply to themselves with a good guidance.

Chemotherapy-related nausea and vomiting are among the symptoms affecting children's quality of life and their adaptation to the treatment. There are limited amount of research intended to manage pediatric oncology patients' chemotherapy-related nausea and vomiting symptoms by using acupressure. It is thought that the research will provide significant contribution for literature, nursing practice and the quality of patient care since power of the study is high and it is the first study which efficiency of wrist-band, manuel acupressure and placebos is being compared for management of chemotherapy-related acute nausea and vomiting symptoms in pediatric oncology patients.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2017-06-06
• Study Completion: 2018-03-01
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Children between the ages of 5-18,
• Who have a chemotherapy protocol with a high and moderate emetogenic effect according to MASCC / ESMO Antiemetic Guidance Classification
• Not having a verbal communication disorder.

Exclusion Criteria

• If the participants did not receive chemotherapy or were receiving it for the first time,
• Branching, redness, phlebitis, edema, open wound, fracture, infection, etc. in the wrist
• Any obstacles for the verbal assessment of the child (intubation, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
manuel acupressure	placebo manuel acupressure	In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects.
sea-band acupressure	sea-band acupressure	In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects.
manuel acupressure	manuel acupressure	In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects.
sea-band acupressure	placebo sea-band	In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects.

Primary Outcome Measures

Name	Time	Method
number and severity of nausea, number and severity of vomiting	during study	Following the interventions, the number of nausea and vomiting experienced by children was followed up for 24 hours. visual severity scale was used to score nausea and vomiting severity. (numeric expression, VAS, 0-10)

Secondary Outcome Measures

Name	Time	Method
antiemetic need	during study	The antiemetic drugs needed by children were recorded for 24 hours after the interventions. (numeric expression, 0-10)

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey