Aromatherapy on Pain and Anxiety of the Patients Undergoing Prostate Biopsy
Condition: Aromatherapy; Prostate Cancer; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The study included 120 male patients who would undergo a prostate biopsy. Patients were
      divided into 3 groups as 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). After
      the procedure, the patient was rested and were again filled out the STAI-1 form. After that,
      the data of all the patients involved in the study was compared.
    

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.
    

Intervention name(s): Aromatherapy
Intervention type(s): Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was designed as a placebo-controlled prospective double-blind study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care