The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children
Primary Purpose
Pediatric Cancer, Nausea With Vomiting Chemotherapy-Induced
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manuel acupressure
sea-band acupressure
placebo manuel acupressure
placebo sea-band
Sponsored by
About this trial
This is an interventional supportive care trial for Pediatric Cancer focused on measuring nursing, child cancer patients, acupressure, Nausea with Vomiting Chemotherapy-Induced, nausea and vomiting, pediatric cancer
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.).
Sites / Locations
- Akdeniz University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
manuel acupressure
sea-band acupressure
Arm Description
In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects.
In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
antiemetic need
The antiemetic drugs needed by children were recorded for 24 hours after the interventions. (numeric expression, 0-10)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651608
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
June 6, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer, Nausea With Vomiting Chemotherapy-Induced
Keywords
nursing, child cancer patients, acupressure, Nausea with Vomiting Chemotherapy-Induced, nausea and vomiting, pediatric cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
manuel acupressure
Arm Type
Experimental
Arm Description
In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects.
Arm Title
sea-band acupressure
Arm Type
Experimental
Arm Description
In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects.
Intervention Type
Behavioral
Intervention Name(s)
manuel acupressure
Intervention Description
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
Intervention Name(s)
sea-band acupressure
Intervention Description
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
Intervention Name(s)
placebo manuel acupressure
Intervention Description
Placebo manual acupress was applied in the next protocol for the child who was administered manual acupressure.
Intervention Type
Behavioral
Intervention Name(s)
placebo sea-band
Intervention Description
Placebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure.
Primary Outcome Measure Information:
Title
number and severity of nausea, number and severity of vomiting
Description
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)
Time Frame
during study
Secondary Outcome Measure Information:
Title
antiemetic need
Description
The antiemetic drugs needed by children were recorded for 24 hours after the interventions. (numeric expression, 0-10)
Time Frame
during study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysegül İŞLER DALGIÇ, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data sharing plans for the current study are unknown and will be made available at a later date.
Citations:
PubMed Identifier
29266260
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.
Results Reference
background
PubMed Identifier
19134445
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.
Results Reference
background
PubMed Identifier
28231440
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.
Results Reference
background
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The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children
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