The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children

March 2, 2021 updated by: Duygu ALTUNTAŞ BALCI, Akdeniz University

Effectiveness of Acupress in The Management of Chemotherapy-Developed Acute Nausea Vomiting Symptoms In Child Oncology Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07000
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: manuel acupressure
In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects.
Behavioral: manuel acupressure
Acupressure was applied once by the researcher 30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child. 3 fingers were placed on the child's wrist with their fingers and the region (point P6) between the flexor carpi radians and palmaris longus 1 cm below. Acupressure was applied to the wrist of the child by press for 2 minutes. The same procedure was applied to the other wrist. Then, data were recorded in accordance with the data collection procedure.
Behavioral: placebo manuel acupressure
Placebo manual acupress was applied in the next protocol for the child who was administered manual acupressure.
Experimental: sea-band acupressure
In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects.
Behavioral: sea-band acupressure
30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child, sea-band acupress was applied by the researcher. The P6 point on the wrist was identified and marked with the child's own fingers. A sea band was attached to both wrists of the child by the researcher. The attached sea-band was allowed to remain for 15 minutes and was removed by the researcher at the end of the period. Separate sea-band was attached to each child. Acupress wrist bands, which are produced in separate sizes for adults and children, were used during the application, taking into account the physical development of the child, pediatric for the age range of 5-12, and adult size sea-band for the age of 12. Acupress application with sea-band was done once. Then, data were recorded in accordance with the data collection procedure
Behavioral: placebo sea-band
Placebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number and severity of nausea, number and severity of vomiting
Time Frame: 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)
during study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antiemetic need
Time Frame: during study
The antiemetic drugs needed by children were recorded for 24 hours after the interventions. (numeric expression, 0-10)
during study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Aysegul ISLER DALGIC, Professor, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

June 6, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYL-2016-1099 (Other Identifier: Akdeniz Üniversitesi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data sharing plans for the current study are unknown and will be made available at a later date.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Cancer

Clinical Trials on manuel acupressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe