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

Primary Purpose

Leukemia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Peppermint Inhalation
Swedish Massage
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia focused on measuring leukemia, Swedish Massage, Peppermint Inhalation, Nausea, Vomiting, Chemotherapy, Children

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eman Arafa Badr

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Peppermint Inhalation Group

Swedish Massage Group:

Arm Description

Children with leukemia received routine nursing and hospital care for management of chemotherapy induced nausea and vomiting (antiemetic medications only).

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.

Children with leukemia received the Swedish massage therapy in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting.

Outcomes

Primary Outcome Measures

Experience of anticipatory nausea
Yes/No
Worst of anticipatory nausea
No/Mild/Moderate/severe/intolerable
Duration of anticipatory nausea
/Minutes
Frequency of anticipatory nausea
once/twice/ three times and more
Experience of anticipatory vomiting
Yes/No
Worst of anticipatory vomiting
No/Mild/Moderate/severe/intolerable
Amount of anticipatory vomiting
Small/ Moderate/ Large
Frequency of anticipatory vomiting
once/ twice/ three times and more.
Experience of acute nausea .
Yes/no.
Worst of acute nausea .
No/Mild/Moderate/severe/intolerable
Duration of acute nausea .
/hours.
Frequency of acute nausea .
once/ twice/ three times and more.
Experience of acute vomiting.
Yes/No.
Worst of acute vomiting.
No/Mild/Moderate/severe/intolerable
Amount of acute vomiting.
Small/ Moderate/ large
Frequency of acute vomiting.
once/ twice/ three times and more.
Experience of delayed nausea.
Yes/ No.
Worst of delayed nausea.
No/Mild/Moderate/severe/intolerable
Duration of delayed nausea.
/hours.
Frequency of delayed nausea.
once/ twice/ three times and more.
Experience of delayed vomiting.
Yes/ No.
Worst of delayed vomiting.
No/Mild/Moderate/severe/intolerable
Amount of delayed vomiting.
Small/ Moderate/ large
Frequency of delayed vomiting.
once/ twice/ three times and more.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2023
Last Updated
October 17, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT06095726
Brief Title
Peppermint Inhalation Versus Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia
Official Title
Comparative Effect of Peppermint Inhalation and Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
leukemia, Swedish Massage, Peppermint Inhalation, Nausea, Vomiting, Chemotherapy, Children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children with leukemia received routine nursing and hospital care for management of chemotherapy induced nausea and vomiting (antiemetic medications only).
Arm Title
Peppermint Inhalation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Swedish Massage Group:
Arm Type
Experimental
Arm Description
Children with leukemia received the Swedish massage therapy in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting.
Intervention Type
Behavioral
Intervention Name(s)
Peppermint Inhalation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Swedish Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Experience of anticipatory nausea
Description
Yes/No
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Worst of anticipatory nausea
Description
No/Mild/Moderate/severe/intolerable
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Duration of anticipatory nausea
Description
/Minutes
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Frequency of anticipatory nausea
Description
once/twice/ three times and more
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Experience of anticipatory vomiting
Description
Yes/No
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Worst of anticipatory vomiting
Description
No/Mild/Moderate/severe/intolerable
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Amount of anticipatory vomiting
Description
Small/ Moderate/ Large
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Frequency of anticipatory vomiting
Description
once/ twice/ three times and more.
Time Frame
assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Title
Experience of acute nausea .
Description
Yes/no.
Time Frame
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.
Title
Worst of acute nausea .
Description
No/Mild/Moderate/severe/intolerable
Time Frame
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.
Title
Duration of acute nausea .
Description
/hours.
Time Frame
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.
Title
Frequency of acute nausea .
Description
once/ twice/ three times and more.
Time Frame
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.
Title
Experience of acute vomiting.
Description
Yes/No.
Time Frame
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.
Title
Worst of acute vomiting.
Description
No/Mild/Moderate/severe/intolerable
Time Frame
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.
Title
Amount of acute vomiting.
Description
Small/ Moderate/ large
Time Frame
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.
Title
Frequency of acute vomiting.
Description
once/ twice/ three times and more.
Time Frame
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.
Title
Experience of delayed nausea.
Description
Yes/ No.
Time Frame
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.
Title
Worst of delayed nausea.
Description
No/Mild/Moderate/severe/intolerable
Time Frame
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.
Title
Duration of delayed nausea.
Description
/hours.
Time Frame
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.
Title
Frequency of delayed nausea.
Description
once/ twice/ three times and more.
Time Frame
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.
Title
Experience of delayed vomiting.
Description
Yes/ No.
Time Frame
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.
Title
Worst of delayed vomiting.
Description
No/Mild/Moderate/severe/intolerable
Time Frame
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.
Title
Amount of delayed vomiting.
Description
Small/ Moderate/ large
Time Frame
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.
Title
Frequency of delayed vomiting.
Description
once/ twice/ three times and more.
Time Frame
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 Pre-specified Outcome Measures:
Title
Child's age
Description
years
Time Frame
Before data collection
Title
Gender
Description
male/female
Time Frame
Before data collection
Title
Residence
Description
rural/urban
Time Frame
Before data collection
Title
Level of education
Description
kinder garden/primary
Time Frame
Before data collection
Title
Onset of the disease
Description
months
Time Frame
Before data collection
Title
Type of leukemia
Description
Acute Lymphoblastic Leukemia / Acute Myeloid Leukemia/ Chronic Lymphocytic Leukemia / Chronic Myeloid Leukemia
Time Frame
Before data collection
Title
Prescribed chemotherapy medications
Description
Methotrexate / cytarabine
Time Frame
Before data collection
Title
Antiemetics prescribed medications
Description
Ondansetron
Time Frame
Before data collection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eman Arafa Badr
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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PubMed Identifier
29947285
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
result

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

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