NCT06095726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

October 4, 2023

Last Update Submit

October 17, 2023

Conditions

Leukemia

Keywords

leukemiaSwedish MassagePeppermint InhalationNauseaVomitingChemotherapyChildren

Outcome Measures

Primary Outcomes (24)

  • 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 Outcomes (8)

  • Child's age

    Before data collection

  • Gender

    Before data collection

  • Residence

    Before data collection

  • +5 more other outcomes

Study Arms (3)

Control group

NO INTERVENTION

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

Peppermint Inhalation Group

EXPERIMENTAL

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

Swedish Massage Group:

EXPERIMENTAL

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

Interventions

Peppermint InhalationBEHAVIORAL

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.

Peppermint Inhalation Group
Swedish MassageBEHAVIORAL

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.

Swedish Massage Group:

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Received first chemotherapy session
  • Intact skin in the massage

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eman Arafa Badr

Alexandria, Egypt

Location

Related Publications (4)

  • 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.

    BACKGROUND

  • 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.

    PMID: 29947285BACKGROUND

  • 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.

    BACKGROUND

  • 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

    RESULT

MeSH Terms

Conditions

LeukemiaNauseaVomiting

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 23, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

EG(1)