Clinical trial NCT06095726: 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
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Keywords: leukemia
Swedish Massage
Peppermint Inhalation
Nausea
Vomiting
Chemotherapy
Children
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Experience of anticipatory nausea
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Worst of anticipatory nausea
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Duration of anticipatory nausea
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Frequency of anticipatory nausea
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Experience of anticipatory vomiting
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Worst of anticipatory vomiting
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Amount of anticipatory vomiting
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Frequency of anticipatory vomiting
timeFrame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
measure: Experience of acute nausea .
timeFrame: 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.
measure: Worst of acute nausea .
timeFrame: 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.
measure: Duration of acute nausea .
timeFrame: 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.
measure: Frequency of acute nausea .
timeFrame: 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.
measure: Experience of acute vomiting.
timeFrame: 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.
measure: Worst of acute vomiting.
timeFrame: 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.
measure: Amount of acute vomiting.
timeFrame: 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.
measure: Frequency of acute vomiting.
timeFrame: 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.
measure: Experience of delayed nausea.
timeFrame: 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.
measure: Worst of delayed nausea.
timeFrame: 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.
measure: Duration of delayed nausea.
timeFrame: 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.
measure: Frequency of delayed nausea.
timeFrame: 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.
measure: Experience of delayed vomiting.
timeFrame: 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.
measure: Worst of delayed vomiting.
timeFrame: 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.
measure: Amount of delayed vomiting.
timeFrame: 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.
measure: Frequency of delayed vomiting.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: Child's age
timeFrame: Before data collection
measure: Gender
timeFrame: Before data collection
measure: Residence
timeFrame: Before data collection
measure: Level of education
timeFrame: Before data collection
measure: Onset of the disease
timeFrame: Before data collection
measure: Type of leukemia
timeFrame: Before data collection
measure: Prescribed chemotherapy medications
timeFrame: Before data collection
measure: Antiemetics prescribed medications
timeFrame: Before data collection
Locations:
city: Alexandria
country: Egypt
facility: Eman Arafa Badr
Study officials:
References:
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.
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.
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.
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