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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095726
• Other study ID #: CINV
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Nausea
• Respiratory Aspiration
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Eman Arafa Badr	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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

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.

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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child's age	years	Before data collection
Other	Gender	male/female	Before data collection
Other	Residence	rural/urban	Before data collection
Other	Level of education	kinder garden/primary	Before data collection
Other	Onset of the disease	months	Before data collection
Other	Type of leukemia	Acute Lymphoblastic Leukemia / Acute Myeloid Leukemia/ Chronic Lymphocytic Leukemia / Chronic Myeloid Leukemia	Before data collection
Other	Prescribed chemotherapy medications	Methotrexate / cytarabine	Before data collection
Other	Antiemetics prescribed medications	Ondansetron	Before data collection
Primary	Experience of anticipatory nausea	Yes/No	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Worst of anticipatory nausea	No/Mild/Moderate/severe/intolerable	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Duration of anticipatory nausea	/Minutes	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Frequency of anticipatory nausea	once/twice/ three times and more	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Experience of anticipatory vomiting	Yes/No	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Worst of anticipatory vomiting	No/Mild/Moderate/severe/intolerable	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Amount of anticipatory vomiting	Small/ Moderate/ Large	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	Frequency of anticipatory vomiting	once/ twice/ three times and more.	assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.