Aromatherapy in Providing a Semen Sample

NCT06241495 | Completed

• 1 other identifier: İ04-205-23
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage. The study will be carried out in two different groups. After the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. The random distribution of men to the study groups will be carried out random. The following applications will be made to the groups. Aromatherapy/placebo will be applied to the individuals included in the study. During the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (3)

• Change in anxiety

  The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

  before providing a semen sample, immediately after providing a semen sample

• Anxiety about providing a semen sample

  VAS is a 10-cm-long measurement tool. The left end of the scale reads "no anxiety " and the right end reads "very anxious". A high score on the scale indicated a high level of anxiety and a score of 0 pointed to no anxiety.

  immediately after providing a semen sample

• Difficulty providing a semen sample

  VAS is a 10-cm-long measurement tool. The left end of the scale reads "not difficult" and the right end reads "very difficult ". A high score on the scale indicated a high level of difficulty and a score of 0 pointed to no difficulty.

  immediately after providing a semen sample

Secondary Outcomes (5)

• Semen volume

  immediately after providing a semen sample

• sperm concentration

  immediately after providing a semen sample

• sperm motility percentage

  immediately after providing a semen sample

• Total sperm count

  immediately after providing a semen sample

• Satisfaction with the oil used

  immediately after providing a semen sample

Study Arms (2)

Aromatherapy

EXPERIMENTAL

Other: Aromatherapy

Control Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Placebo oil will be applied to the individuals included in the study. During the semen sample giving process, coconut oil (placebo) will be applied with a diffuser.

Control Group

Aromatherapy OTHER

Aromatherapy will be applied to the individuals included in the study. During the semen sample giving process, lavender oil will be applied with a diffuser.

Aromatherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having applied to the center where the research will be conducted with a complaint of infertility
• Being 18 years or older

You may not qualify if:

• Individuals giving up on participating in the study
• Participant not being able to provide a semen sample
• Being diagnosed with azoospermia-oligozoospermia

Sponsors & Collaborators

• Menekşe Nazlı AKER: lead

Study Sites (1)

Ankara University Fertility Diagnosis, Treatment, Research and Application Center

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 5, 2024
• Study Start: January 29, 2024
• Primary Completion: August 28, 2024
• Study Completion: August 30, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-01

Locations

TU (1)