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The goal of this clinical trial is to learn if essential oil aromatherapy works to improve urinary symptoms in adults with multiple sclerosis. It will also learn about the safety of essential oil use in this population.
The main questions it aims to answer are:
Researchers will compare essential oil aromatherapy to a placebo (a look-alike neutral oil with no therapeutic properties) to see if essential oil aromatherapy works to improve urinary symptoms in multiple sclerosis patients.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Oil Aromatherapy Group | Experimental |
| |
| Placebo Oil Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential Oil Blend (Lavender, Rosemary) | Other | This intervention consists of a standardized topical blend of Lavender (Lavandula angustifolia) at 3% and Rosemary (Rosmarinus officinalis) at 2%, diluted in apricot kernel oil as a carrier. The blend was formulated to target neurogenic lower urinary tract symptoms in patients with multiple sclerosis, based on the antispasmodic properties of Lavender and the neuromodulatory and anti-inflammatory properties of Rosemary. The essential oils used are batch-controlled for chemical purity and concentration. The blend is applied topically via gentle circular massage on the lower abdomen, for a total duration of 6 consecutive weeks. This specific combination, route of administration, and target population distinguish this intervention from other aromatherapy studies that have used single oils, inhalation methods, or non-neurological populations. |
| Measure | Description | Time Frame |
|---|---|---|
| Overactive Bladder Symptom Score (OABSS) | Overactive Bladder Symptom Score (OABSS) (Overactive Bladder Symptom Score) Scale range: minimum 0 - maximum 15. Higher scores indicate a worse outcome (greater severity of overactive bladder symptoms). [Time Frame: Baseline and Week 6] | Baseline, and Week 6 |
| Qualiveen questionnaire | Qualiveen - Urinary Disorder-Specific Quality of Life Questionnaire (Qualiveen, Domain 1: "Bother with Limitations") Scale range: minimum 0 - maximum 4 per item (9 items, total domain score = sum of items ÷ 9). Higher scores indicate a worse outcome (greater bother related to urinary problems). [Time Frame: Baseline and Week 6] | Baseline and Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zitouni-Nourine Saida Hanane | Contact | +213556623080 | zitouni.saida@univ-oran1.dz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aboubakr abdelmadjid | Oran | Oran Province | 31000 | Algeria |
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| Neutral Carrier Oil (Apricot Kernel Oil) | Other | This intervention consists of pure Apricot Kernel oil, used as an inert placebo comparator. The placebo oil contains no active essential oils or therapeutic compounds. It is identical to the experimental intervention in terms of appearance, color, viscosity, volume, packaging, and method of application, ensuring effective masking of participants and outcome assessors. The placebo oil is applied topically via gentle circular massage on the lower abdomen, for a total duration of 6 consecutive weeks, mirroring exactly the administration protocol of the experimental arm. |
|
| Zitouni-Nourine Saida Hanane | Oran | Algeria |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D001750 | Urinary Bladder, Neurogenic |
| D014549 | Urinary Incontinence |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
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