- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241495
Aromatherapy in Providing a Semen Sample
The Effect of Aromatherapy on Anxiety, Difficulty in Providing a Semen Sample and Semen Parameters
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey
- Ankara University Fertility Diagnosis, Treatment, Research and Application Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having applied to the center where the research will be conducted with a complaint of infertility
- Being 18 years or older
Exclusion Criteria:
- Individuals giving up on participating in the study
- Participant not being able to provide a semen sample
- Being diagnosed with azoospermia-oligozoospermia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control Group
|
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.
|
|
Experimental: Aromatherapy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety
Time Frame: before providing a semen sample, immediately after providing a semen sample
|
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
Time Frame: immediately after 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
Time Frame: immediately after 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semen volume
Time Frame: immediately after providing a semen sample
|
Volume of semen sample
|
immediately after providing a semen sample
|
|
sperm concentration
Time Frame: immediately after providing a semen sample
|
sperm concentration of semen sample
|
immediately after providing a semen sample
|
|
sperm motility percentage
Time Frame: immediately after providing a semen sample
|
sperm motility percentage of semen sample
|
immediately after providing a semen sample
|
|
Satisfaction with the oil used
Time Frame: immediately after providing a semen sample
|
VAS is a 10-cm-long measurement tool.
The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied".
A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
|
immediately after providing a semen sample
|
|
Total sperm count
Time Frame: immediately after providing a semen sample
|
Total sperm count of semen sample
|
immediately after providing a semen sample
|
Collaborators and Investigators
Sponsor
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
- İ04-205-23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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