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

Not Applicable

Completed

• Conditions: Leukemia
• Interventions: Behavioral: Peppermint Inhalation; Behavioral: Swedish Massage

• Registration Number: NCT06095726
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-17
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peppermint Inhalation Group	Peppermint Inhalation	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.
Swedish Massage Group:	Swedish Massage	Children with leukemia received the Swedish massage therapy in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting.

Primary Outcome Measures

Name	Time	Method
Frequency of anticipatory vomiting	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	once/ twice/ three times and more.
Experience of acute nausea .	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.	Yes/no.
Duration of acute nausea .	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.	/hours.
Amount of acute vomiting.	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.	Small/ Moderate/ large
Experience of delayed nausea.	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.	Yes/ No.
Amount of delayed vomiting.	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.	Small/ Moderate/ large
Experience of anticipatory nausea	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	Yes/No
Frequency of anticipatory nausea	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	once/twice/ three times and more
Frequency of acute nausea .	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.	once/ twice/ three times and more.
Frequency of acute vomiting.	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.	once/ twice/ three times and more.
Duration of anticipatory nausea	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	/Minutes
Experience of anticipatory vomiting	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	Yes/No
Worst of anticipatory nausea	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	No/Mild/Moderate/severe/intolerable
Worst of anticipatory vomiting	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	No/Mild/Moderate/severe/intolerable
Amount of anticipatory vomiting	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions	Small/ Moderate/ Large
Worst of acute nausea .	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.	No/Mild/Moderate/severe/intolerable
Experience of acute vomiting.	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.	Yes/No.
Worst of acute vomiting.	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.	No/Mild/Moderate/severe/intolerable
Experience of delayed vomiting.	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.	Yes/ No.
Worst of delayed vomiting.	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.	No/Mild/Moderate/severe/intolerable
Worst of delayed nausea.	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.	No/Mild/Moderate/severe/intolerable
Duration of delayed nausea.	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.	/hours.
Frequency of delayed nausea.	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.	once/ twice/ three times and more.
Frequency of delayed vomiting.	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.	once/ twice/ three times and more.

Trial Locations

Locations (1)

Eman Arafa Badr; 🇪🇬 Alexandria, Egypt