Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia

NCT ID: NCT03304938

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-12-01

Brief Summary

This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

Detailed Description

Considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender in treatment of sleep disorders in this study the efficacy of Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be investigated. This study is designed as cross-over double-blind placebo-controlled randomized clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention and first placebo groups.The primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the end of the study.

Conditions

Diabetes Mellitus, Type 2; Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lavender oil

Group Type: ACTIVE_COMPARATOR

Lavender Oil

Intervention Type: DRUG

The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks

vehicle (Almond oil)

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks

Interventions

Lavender Oil

The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks

Intervention Type: DRUG

Placebos

The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diabetes mellitus type 2
• Age between 25-65 years old
• Fasting Blood Sugar between 70-130
• 2 hour post prandial glucose less than 180.
• HbA1C less than 7
• Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.

Exclusion Criteria

• Any systemic illnesses
• Use of sedative or antidepressant drugs
• Pregnancy
• Lactation
• History of allergic reaction to Lavender
• History of allergic rhinitis, asthma and respiratory disorders
• Anosmia
• Headache that start with smell
• Cigarette smocking or substance abuse
• Hospitalization or surgery within 1 months ago.
• Work shift

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mesbah Shams, MD

Associate professor of internal medicine and endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mesbah Shams, M.D.

Role: STUDY_CHAIR

Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

Locations

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

95010112052

Identifier Type: -

Identifier Source: org_study_id