Effect of Aromatherapy Massage on Symptom Control
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The population of the study will consist of patients who underwent colorectal cancer surgery between June 2021 and June 2022, and the sample of patients who meet the criteria for inclusion in the study.The sample was planned to be 90 people, 30 patients for each of the aromatherapy massage, classica...
The population of the study will consist of patients who underwent colorectal cancer surgery between June 2021 and June 2022, and the sample of patients who meet the criteria for inclusion in the study.The sample was planned to be 90 people, 30 patients for each of the aromatherapy massage, classical foot massage and control groups. However, power analysis was also performed to calculate the minimum sample size to be reached. In the study, it was aimed to evaluate the differences in mean scale between three groups, including one control and two experiments. When it is not known how many units of difference between groups are important, the effect width value is taken as 0.35 as the method used. The effect width value gives results with a very high constraint of 0.10, medium level of 0.25 and a maximum acceptance constraint of 0.40. The total number of patients was 84, including 28 patients in the groups, with an error margin of 5% and a width of effect value of 0.35 at 81.19% power level.Block Randomization technique will be used in the sample selection of the research. In order to blind the randomization, it was made by a statistician who was not related to the research and the group rankings were put in 9 envelopes and numbered by another person who was not related to the research. For data collection Patient Information Form , Visual Analog Scale (VAS-Pain), Visual Analog Scale (VAS-Fatigue), Richard-Campbell Sleep Quality Scale, State Anxiety Scale, Post-operative Nausea-Vomiting Effect Scale will be used.The first interview with the patients will be held in the preoperative period and information will be given about the research. For patients who agree to participate in the study, a Patient Information Form will be filled out and a group assignment will be made using the block randomization method. In patients assigned to the aromatherapy massage group, a patch test will be applied to the inner elbow area to evaluate the allergy status against aromatic oils. In the patch test, it is recommended to drop the diluted essential oil into the inner elbow area and to follow the development of allergic reaction after 24 hours by wrapping it with a transparent cover. Allergy development status will be evaluated 24 hours after the test, and the test result will be shown to a dermatologist. The study will start according to the opinion received.
Tracking Information
- NCT #
- NCT04810299
- Collaborators
- Not Provided
- Investigators
- Study Director: Dilek AYG?N, PhD Sakarya University