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NCT Number: NCT06095726

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Nausea Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eman Arafa Badr

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peppermint Inhalation

Behavioral

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

Behavioral

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 outcomes

  1. Experience of anticipatory nausea

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    Yes/No

  2. Worst of anticipatory nausea

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    No/Mild/Moderate/severe/intolerable

  3. Duration of anticipatory nausea

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    /Minutes

  4. Frequency of anticipatory nausea

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    once/twice/ three times and more

  5. Experience of anticipatory vomiting

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    Yes/No

  6. Worst of anticipatory vomiting

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    No/Mild/Moderate/severe/intolerable

  7. Amount of anticipatory vomiting

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    Small/ Moderate/ Large

  8. Frequency of anticipatory vomiting

    Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions

    once/ twice/ three times and more.

  9. Experience of acute nausea .

    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.

    Yes/no.

  10. Worst of acute nausea .

    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.

    No/Mild/Moderate/severe/intolerable

  11. Duration of acute nausea .

    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.

    /hours.

  12. Frequency of acute nausea .

    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.

    once/ twice/ three times and more.

  13. Experience of acute vomiting.

    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.

    Yes/No.

  14. Worst of acute vomiting.

    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.

    No/Mild/Moderate/severe/intolerable

  15. Amount of acute vomiting.

    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.

    Small/ Moderate/ large

  16. Frequency of acute vomiting.

    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.

    once/ twice/ three times and more.

  17. Experience of delayed nausea.

    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.

    Yes/ No.

  18. Worst of delayed nausea.

    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.

    No/Mild/Moderate/severe/intolerable

  19. Duration of delayed nausea.

    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.

    /hours.

  20. Frequency of delayed nausea.

    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.

    once/ twice/ three times and more.

  21. Experience of delayed vomiting.

    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.

    Yes/ No.

  22. Worst of delayed vomiting.

    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.

    No/Mild/Moderate/severe/intolerable

  23. Amount of delayed vomiting.

    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.

    Small/ Moderate/ large

  24. Frequency of delayed vomiting.

    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.

    once/ twice/ three times and more.

Other outcomes

  1. Child's age

    Time frame: Before data collection

    years

  2. Gender

    Time frame: Before data collection

    male/female

  3. Residence

    Time frame: Before data collection

    rural/urban

  4. Level of education

    Time frame: Before data collection

    kinder garden/primary

  5. Onset of the disease

    Time frame: Before data collection

    months

  6. Type of leukemia

    Time frame: Before data collection

    Acute Lymphoblastic Leukemia / Acute Myeloid Leukemia/ Chronic Lymphocytic Leukemia / Chronic Myeloid Leukemia

  7. Prescribed chemotherapy medications

    Time frame: Before data collection

    Methotrexate / cytarabine

  8. Antiemetics prescribed medications

    Time frame: Before data collection

    Ondansetron

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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