Aromatherapy on Pain and Anxiety of the Patients Undergoing Prostate Biopsy

NCT06119438 | Completed

• 1 other identifier: 375/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aromatherapy; Prostate Cancer; Anxiety

Outcome Measures

Primary Outcomes (1)

• The STAI index

  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.

Study Arms (3)

Saline group

ACTIVE COMPARATOR

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

Other: Aromatherapy

Levander group

ACTIVE COMPARATOR

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.

Other: Aromatherapy

Frankincense group

ACTIVE COMPARATOR

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.

Other: Aromatherapy

Interventions

Aromatherapy OTHER

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

Frankincense group; Levander group; Saline group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: patients underwent prostate biopsy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing prostate biopsy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Barış Saylam

Mersin, Mezitli, 33240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Model Details: The study was designed as a placebo-controlled prospective double-blind study

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)