The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children

NCT ID: NCT04651608

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Pediatric Cancer Nausea With Vomiting Chemotherapy-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

One of the 2 procedure groups randomized with sealed envelope was applied acupressure with pressure to the P-6 point on the wrist of the child by the researcher in the first application, the other is applied with sea-band, and it was followed for 24 hours. Acupressure application was performed on both wrists for 2 minutes each with pressure, and 15 minutes each with sea-band. In the next chemotherapy treatment, a placebo of the first procedure (placebo pressure/placebo sea-band) was applied to each child, which ensured the control group of their own.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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manuel acupressure

In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects.

Group Type EXPERIMENTAL

manuel acupressure

Intervention Type BEHAVIORAL

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.

placebo manuel acupressure

Intervention Type BEHAVIORAL

Placebo manual acupress was applied in the next protocol for the child who was administered manual acupressure.

sea-band acupressure

In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects.

Group Type EXPERIMENTAL

sea-band acupressure

Intervention Type BEHAVIORAL

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

placebo sea-band

Intervention Type BEHAVIORAL

Placebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure.

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

placebo manuel acupressure

Placebo manual acupress was applied in the next protocol for the child who was administered manual acupressure.

Intervention Type BEHAVIORAL

placebo sea-band

Placebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.).
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Duygu ALTUNTAŞ BALCI

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aysegül İŞLER DALGIÇ, Professor

Role: STUDY_DIRECTOR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dupuis LL, Kelly KM, Krischer JP, Langevin AM, Tamura RN, Xu P, Chen L, Kolb EA, Ullrich NJ, Sahler OJZ, Hendershot E, Stratton A, Sung L, McLean TW. Acupressure bands do not improve chemotherapy-induced nausea control in pediatric patients receiving highly emetogenic chemotherapy: A single-blinded, randomized controlled trial. Cancer. 2018 Mar 15;124(6):1188-1196. doi: 10.1002/cncr.31198. Epub 2017 Dec 19.

Reference Type BACKGROUND
PMID: 29266260 (View on PubMed)

Jones E, Isom S, Kemper KJ, McLean TW. Acupressure for chemotherapy-associated nausea and vomiting in children. J Soc Integr Oncol. 2008 Fall;6(4):141-5.

Reference Type BACKGROUND
PMID: 19134445 (View on PubMed)

Miao J, Liu X, Wu C, Kong H, Xie W, Liu K. Effects of acupressure on chemotherapy-induced nausea and vomiting-a systematic review with meta-analyses and trial sequential analysis of randomized controlled trials. Int J Nurs Stud. 2017 May;70:27-37. doi: 10.1016/j.ijnurstu.2017.02.014. Epub 2017 Feb 14.

Reference Type BACKGROUND
PMID: 28231440 (View on PubMed)

Other Identifiers

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TYL-2016-1099

Identifier Type: OTHER

Identifier Source: secondary_id

TYL-2016-1099

Identifier Type: -

Identifier Source: org_study_id

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