Peppermint Inhalation Versus Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia

Comparative Effect of Peppermint Inhalation and Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia.

Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage on chemotherapy induced-nausea and vomiting in children with leukemia. the main research hypotheses are:

• Children with leukemia who receive peppermint inhalation exhibit less chemotherapy induced- nausea and vomiting than those who don't receive.
• Children with leukemia who receive Swedish massage exhibit less chemotherapy induced-nausea and vomiting than those who don't receive.
• Children with leukemia who receive Swedish massage exhibit less chemotherapy induced- nausea and vomiting than those who receive peppermint inhalation. children divided into three groups of study ( control group, peppermint inhalation group and Swedish massage group) to identify its effect on chemotherapy induced nausea and vomiting.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Behavioral: Peppermint Inhalation; Behavioral: Swedish Massage

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Eman Arafa Badr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Received first chemotherapy session
• Intact skin in the massage

Exclusion Criteria:

• Chronic and acute disorders such as respiratory, cardiovascular diseases...etc.
• Allergy from any essential oils.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Children with leukemia received routine nursing and hospital care for management of chemotherapy induced nausea and vomiting (antiemetic medications only).
Experimental: Peppermint Inhalation Group; Children with leukemia received the inhalation of essential oil of peppermint 2% in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting.	Behavioral: Peppermint Inhalation; The researcher applied two drops (0,2ml) of 2% essential oil of peppermint on a piece of cotton. Then, each child was instructed to take three breaths of the essence that had been put on a piece of cotton before starting chemotherapy session with three minutes. In addition, the piece of cotton with peppermint essence was kept at bed side table to use by child as needed throughout the chemotherapy session. Inhalation of peppermint essence was applied for three consecutive chemotherapy sessions.
Experimental: Swedish Massage Group: Children with leukemia received the Swedish massage therapy in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting.	Behavioral: Swedish Massage; Children were received Swedish massage therapy for twenty minutes prior to chemotherapy session in a private and special room with effleurage, petrissage, friction, and tapotement and vibration movements for three consecutive chemotherapy sessions. The researcher applied facilitating olive oil in hands and pre warmed before applying massage. The massage technique was applied in prone position with mild to moderate pressure with guidance by the child's feedback and tolerance by using non-scented olive oil. Children's privacy was considered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of anticipatory nausea	Yes/No	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Worst of anticipatory nausea	No/Mild/Moderate/severe/intolerable	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Duration of anticipatory nausea	/Minutes	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Frequency of anticipatory nausea	once/twice/ three times and more	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Experience of anticipatory vomiting	Yes/No	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Worst of anticipatory vomiting	No/Mild/Moderate/severe/intolerable	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Amount of anticipatory vomiting	Small/ Moderate/ Large	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Frequency of anticipatory vomiting	once/ twice/ three times and more.	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Experience of acute nausea .	Yes/no.	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Worst of acute nausea .	No/Mild/Moderate/severe/intolerable	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Duration of acute nausea .	/hours.	Frst 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Frequency of acute nausea .	once/ twice/ three times and more.	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Experience of acute vomiting.	Yes/No.	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Worst of acute vomiting.	No/Mild/Moderate/severe/intolerable	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Amount of acute vomiting.	Small/ Moderate/ large	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Frequency of acute vomiting.	once/ twice/ three times and more.	First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Experience of delayed nausea.	Yes/ No.	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Worst of delayed nausea.	No/Mild/Moderate/severe/intolerable	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Duration of delayed nausea.	/hours.	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Frequency of delayed nausea.	once/ twice/ three times and more.	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Experience of delayed vomiting.	Yes/ No.	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Worst of delayed vomiting.	No/Mild/Moderate/severe/intolerable	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Amount of delayed vomiting.	Small/ Moderate/ large	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Frequency of delayed vomiting.	once/ twice/ three times and more.	On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child's age	years	Before data collection
Gender	male/female	Before data collection
Residence	rural/urban	Before data collection
Level of education	kinder garden/primary	Before data collection
Onset of the disease	months	Before data collection
Type of leukemia	Acute Lymphoblastic Leukemia / Acute Myeloid Leukemia/ Chronic Lymphocytic Leukemia / Chronic Myeloid Leukemia	Before data collection
Prescribed chemotherapy medications	Methotrexate / cytarabine	Before data collection
Antiemetics prescribed medications	Ondansetron	Before data collection

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• Sowmiya Rajendran, Ruthrani Princely J, Kanchana S, Celina D., Effectiveness of Swedish Massage on the Level of Chemotherapy Induced Nausea and Vomiting (CINV) Among Children with Cancer at a Selected Hospital in North India, ICCRJNR, Jul - Dec 2016, 1(2): 20-38.
• Evans A, Malvar J, Garretson C, Pedroja Kolovos E, Baron Nelson M. The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):392-398. doi: 10.1177/1043454218782133. Epub 2018 Jun 27.
• El-SayedYousef, Y., Zaki, N. A., AsmaaAbd-Alasis, Abdel-RazikSayed, H., & Elsayed, F. (2018). Effect of Therapeutic Massage on nausea and vomitingamong Children with Leukemia following Chemotherapy.
• Ahmad, M. (2016). Tool Development to Assess Nausea and Vomiting Among Patients Receiving Chemotherapy. International Journal of Cancer and Oncology, 3(1), 1-5. https://doi.org/10.15436/2377-0902.16.031

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Children; Nausea; Vomiting; Chemotherapy; leukemia; Swedish Massage; Peppermint Inhalation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Respiration Disorders; Signs and Symptoms, Digestive; Nausea; Vomiting; Respiratory Aspiration; Leukemia
• Other Study ID Numbers: CINV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No