Infertility, Male Clinical Trial
Official title:
The Effect of Aromatherapy on Anxiety, Difficulty in Providing a Semen Sample and Semen Parameters
| Verified date | February 2024 |
| Source | Ankara University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 102 |
| Est. completion date | April 30, 2024 |
| Est. primary completion date | April 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Menekse Nazli AKER |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Semen volume | Volume of semen sample | immediately after providing a semen sample | |
| Secondary | sperm concentration | sperm concentration of semen sample | immediately after providing a semen sample | |
| Secondary | sperm motility percentage | sperm motility percentage of semen sample | immediately after providing a semen sample | |
| Secondary | Satisfaction with the oil used | 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 |
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