Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05658367 |
Other study ID # |
mataseven |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 17, 2022 |
Est. completion date |
March 25, 2023 |
Study information
Verified date |
March 2022 |
Source |
Istanbul Medipol University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Breast cancer ranks first among the most common cancers in women in Turkey, and one out of
every four women diagnosed in 2014 was breast cancer (Turkish Ministry of Health Public
Health Institution, Turkey Cancer Statistics, 2017). Breast cancer is considered both a local
and systemic disease. In the planning of the treatment, the decision of surgery is made by
considering the stage of cancer, and the most frequently applied intervention is mastectomy,
which involves the partial or complete removal of the breast tissue (Turkish Ministry of
Health, General Directorate of Health Services. Breast Cancer Prevention, Screening,
Diagnosis, Treatment, and Follow-up Clinical Guide, 2020; Tola et al., 2021). It is stated
that in patients who have undergone breast surgery, especially during axillary lymph node
dissection, due to the possibility of intercostobrachial nerve injury, pain, numbness, and
weakness may be felt in the chest wall, arm, and shoulder in the postoperative period,
acute/chronic, neuropathic and phantom pain, lymphedema may develop (Ozmen, 2012; Nemli et
al., 2017). Post-operative pain decreases in the first few days, but in some patients, the
severity of pain does not decrease or even increase despite post-operative pain management
(Mc Mahon et al., 2013). Anxiety experienced by patients in the preoperative period,
including breast cancer patients, is an important factor in the level of pain intensity felt
after surgery (Stamenkovic et al., 2018; Kulkarni et al., 2017). Effective anxiety and acute
pain management are important in terms of shortening the recovery period of the individual,
reducing the treatment costs, preventing the occurrence of chronic pain, and increasing the
quality of life. For this reason, it is mentioned that non-pharmacological methods can be
used in addition to pharmacological treatment to assist treatment (Chou et al., 2016; Small
and Laycock, 2020; Reisli et al., 2021). Today, it is known that aromatherapy has an
important place among complementary and holistic therapy methods (Zor et al., 2021). However,
it is stated that the studies on aromatherapy massage are weak in terms of evidence and more
studies should be done on this subject (Ayik and Ozden, 2018). It is stated that aromatherapy
oils are applied by inhalation method alone rather than applied with massage, there are few
studies on the effectiveness of massage with aromatic oils, therefore more studies on
aromatherapy massage should be done in the treatment of pain, anxiety, and depression
(Crosby, 2018; Raffi, 2020).
It is seen that studies conducted after breast surgery are mostly focused on the development
of chronic pain rather than acute pain intensity after surgery (Kulkarni et al., 2017). In
the literature, the effects of aromatherapy massage on anxiety and acute pain severity in
patients who are planning for breast surgery are examined, foot reflexology or classical
massage (Dion et al., 2015) according to the massage area preferred by the patient in the
postoperative period, classical massage applied to the chest region in the preoperative
period (Dion et al., 2015). Xiao et al., 2018) there is research on interventions.
No clinical study was found that evaluated the severity of acute pain and anxiety level in
the arm after Simple Mastectomy (SM) / Modified Radical Mastectomy (MRM) surgery with sesame
oil, sesame-lavender oil mixture, and aromatherapy massage applied in the postoperative
period. Therefore, the result of this study is important because it forms the basis for a
clinical study.
With the results to be obtained from the research; It is aimed at better understanding the
effects of these herbal-based agents in aromatherapy treatment, contributing to nurses'
non-pharmacological treatment interventions, and providing quality care in the management of
anxiety and acute pain in patients, and thus to provide new information to evidence-based
nursing practices.