The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children

NCT04651608 | Completed

• 1 other identifier: TYL-2016-1099
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer; Nausea With Vomiting Chemotherapy-Induced

Keywords

nursing; child cancer patients; acupressure; Nausea with Vomiting Chemotherapy-Induced; nausea and vomiting; pediatric cancer

Outcome Measures

Primary Outcomes (1)

• number and severity of nausea, number and severity of vomiting

  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 Outcomes (1)

• antiemetic need

  during study

Study Arms (2)

manuel acupressure

EXPERIMENTAL

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

Behavioral: manuel acupressure; Behavioral: placebo manuel acupressure

sea-band acupressure

EXPERIMENTAL

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

Behavioral: sea-band acupressure; Behavioral: placebo sea-band

Interventions

manuel acupressure 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.

manuel acupressure

sea-band acupressure 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

sea-band acupressure

placebo manuel acupressure BEHAVIORAL

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

manuel acupressure

placebo sea-band BEHAVIORAL

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

sea-band acupressure

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 29266260 BACKGROUND

• 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.

  PMID: 19134445 BACKGROUND

• 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.

  PMID: 28231440 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysegül İŞLER DALGIÇ, Professor

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: December 3, 2020
• Study Start: March 1, 2017
• Primary Completion: June 6, 2017
• Study Completion: March 1, 2018
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)