Clinical trial NCT04651608: The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children
Official title: Effectiveness of Acupress in The Management of Chemotherapy-Developed Acute Nausea Vomiting Symptoms In Child Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Nausea With Vomiting Chemotherapy-Induced
Keywords: nursing
child cancer patients
acupressure
Nausea with Vomiting Chemotherapy-Induced
nausea and vomiting
pediatric cancer
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 44
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: number and severity of nausea, number and severity of vomiting
timeFrame: during study
Secondary outcomes:
measure: antiemetic need
timeFrame: during study
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Aysegül İŞLER DALGIÇ, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.