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Enrolling By Invitation
NCT05658367
Effect of Aromatherapy Massage on Pain and Anxiety After Mastectomy
Conditions: Acute Pain, Anxiety, Mastectomy, Massage Therapy, Aromatherapy
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: Istanbul Medipol University Hospital
Location: Turkey
Summary
This study is an interventional type three-group randomized controlled non-drug clinical trial aimed at targeting the acute pain content and anxiety level of aromatherapy arm treatment with a sesame oil and sesame lavender oil mixture performed with Simple Mastectomy (BM) / Modified Radical Mastectomy (MRM).
It constitutes a total of 66 patients with the power to represent the universe.
However, considering the losses that may occur during the study process, it was decided that it would be appropriate to include 90 patients, 36% more than the sample.
Individuals receiving arm massage with sesame oil (Group I), individuals performing arm massage with sesame-lavender oil mixture (Group II), and individuals performing arm massage with paraffin oil (Group III) constitute the research groups.
After obtaining the informed written consent of the participants who agreed to participate in the study, the randomization list created from the computer-based random numbers table will be used with the block randomization method to assign an equal number of people to all three groups.
In the preoperative period, patients will be given an allergic sensitivity (patch) test of the oils to be used in the study to Groups 1 and 2, massage training will be given to all groups with the show-and-have method in the pre-operative period, a massage application brochure and video will be given, and information will be given on how to fill out the follow-up forms.
H1: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with sesame oil reduces the severity of acute arm pain compared to massage with paraffin oil.H2: After simple mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces the severity of acute arm pain compared to massage with paraffin oil.H3: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with sesame oil reduces anxiety levels compared to massage with paraffin oil.H4: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces anxiety levels compared to massage with paraffin oil.H5: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces the severity of acute arm pain compared to massage with sesame oil.H6: After Simple Mastectomy (BM)/Modified Radical Mastectomy (MRM), massage with a sesame-lavender oil mixture reduces anxiety levels compared to massage with sesame oil.
Eligibility Criteria
Inclusion criteria;18 years and over,literate,Agreeing to participate in the study,Person, place, and time orientation,Visual (except for those with better vision using a visual aid), auditory communication difficulties (except for those with better hearing ability using a hearing aid) that will prevent them from understanding the information given and expressing the pain situation correctly,No speech impediment/communication problem,Simple mastectomy (BM) and modified radical mastectomy (MRM) were performed,Not using any TAT method,Able to use technology (smartphone, computer, etc.),Individuals with technology devices (smartphone, tablet, computer, etc.)Exclusion criteria;Not speaking Turkish and illiterate in Turkish,Those who are allergic to the oils to be used in the massage during the application,Involved in a different study conducted in the clinic,Breast prosthesis placed during surgery,Having physical and cognitive problems at a level that cannot apply massage,Individuals diagnosed with mood disorders (using any medication for depression, panic attacks, dysthymia, or bipolar disorder)Transferred to the intensive care unit in the postoperative period,Severe bleeding, hematoma, seroma, nerve injury, or lymphedema developing in the postoperative period,Developing an allergy to the oils to be used in the massage during the application,Those who want to leave work voluntarily,Individuals who do not comply with the working process and conditions will be excluded from the study.
Source: ClinicalTrials.gov (NCT05658367). StuddyBuddy aggregates publicly available trial information.
