- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06119438
Aromatherapy on Pain and Anxiety of the Patients Undergoing Prostate Biopsy
The Effect of Inhalation Aromatherapy on Pain and Anxiety Levels of The Patients Undergoing Prostate Biopsy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was conducted at Mersin University Medical Faculty Hospital Urology Department and Mersin City Training and Research Hospital Urology Department. The study was designed as a placebo-controlled prospective double-blind study. Approval was obtained from the Mersin University Ethics Committee for the study (13.05.2020, 375). All patients who participated were informed about the study and received written consent. The study included 120 male patients who would undergo a prostate biopsy. Exclusion criteria were identified as; patients with pain prior to the procedure (VAS value is non-zero), any respiratory disease (lung cancer, asthma, bronchitis, chronic obstructive pulmonary disease, etc.), patients using painkillers in the last 3 hours, patients who were disturbed by the smell of used essential oils and patients with a known allergy to used essential oils with a history of contact dermatitis against cosmetic odor. Patients with these characteristics were not included in the study. During transrectal ultrasound-guided prostate biopsy, periprostatic local anesthesia was routinely administered to all patients and is routinely performed in all prostate biopsies performed in the clinic. Patients have filled out STAI-2 (trait index) forms before the procedure. The STAI clearly distinguishes between the temporary situation of state anxiety and the more general and long-term quality of trait anxiety. The STAI index has 2 subheadings, STAI-1 (state index) and STAI-2 (trait index), with 40 questions. The scores of each subscale could range from a minimum of 20 to a maximum of 80. A score of 20-31 reflected mild anxiety, 32-42 below moderate anxiety, 43-53 above moderate anxiety, 54-64 relatively severe anxiety, and 65-75 severe anxiety. Patients were grouped and randomized according to the STAI-2 (trait index) scores.
Patients were divided into 3 groups placebo group (n = 40), Levander group (N = 40), and Frankincense group (n = 40). Aromatherapy agents were added to the nebulizer at a rate of 2%. Only saline solution was applied to the placebo group. The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure. Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure. The level of anxiety was evaluated by the State Anxiety Inventory (STAI-I). The STAI-1 form was used to determine the transitory emotional state and anxiety level of the participants before and after the procedure. The interrogation procedures were carried out by an assistant doctor who had no knowledge about the study. After the procedure, the patient was rested and again filled out the STAI-1 form. After that, the data of all the patients involved in the study was compared.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mezitli
-
Mersin, Mezitli, Turkey, 33240
- Barış Saylam
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing prostate biopsy
Exclusion Criteria:
- Patients with pain prior to the procedure (VAS value is non-zero),
- Patients with respiratory disease (lung cancer, asthma, bronchitis, chronic obstructive pulmonary disease, etc.),
- Patients using painkillers in the last 3 hours,
- Patients who were disturbed by the smell of used essential oils
- Patients with a known allergy to used essential oils with a history of contact dermatitis against cosmetic odor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Saline group
Only saline solution was applied to the placebo group.
The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure.
Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated on during the procedure
|
Aromatherapy is a TAT (Tapas Acupressure technique) method in which essential oils created from fragrant parts of plants are absorbed from the body and show their effects.
The therapeutic, disease-relieving or preventive properties of essential oils are utilized
|
Active Comparator: Levander group
Levander oil was added to the nebulizer at a rate of 2%.
The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure.
Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure.
|
Aromatherapy is a TAT (Tapas Acupressure technique) method in which essential oils created from fragrant parts of plants are absorbed from the body and show their effects.
The therapeutic, disease-relieving or preventive properties of essential oils are utilized
|
Active Comparator: Frankincense group
Frankincense oil was added to the nebulizer at a rate of 2%.
Only saline solution was applied to the placebo group.
The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure.
Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure.
|
Aromatherapy is a TAT (Tapas Acupressure technique) method in which essential oils created from fragrant parts of plants are absorbed from the body and show their effects.
The therapeutic, disease-relieving or preventive properties of essential oils are utilized
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The STAI index
Time Frame: Immediately after the procedure.
|
The STAI-1 form was used to determine the transitory emotional state and anxiety level of the participants before and after the procedure.
The STAI index has 2 subheadings, STAI-1 (state index) and STAI-2 (trait index), with a total of 40 questions.
The scores of each subscale could range from a minimum of 20 to a maximum of 80. Higher scores are positively correlated with higher levels of anxiety.
A score of 20-31 reflected mild anxiety, 32-42 below moderate anxiety, 43-53 above moderate anxiety, 54-64 relatively severe anxiety, and 65-75 severe anxiety distinguishes between the temporary situation of state anxiety and the more general and long-term quality of trait anxiety.
|
Immediately after the procedure.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 375/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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