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Effect of aromatherapy and counseling based on mindfulness on sexual function, anxiety, and serum level of some bio-markers in postmenopausal women

Effect of aromatherapy with essential oil of lavender-bergamot, and counseling based on mindfulness on sexual function, anxiety, and serum level of some bio-markers in postmenopausal women: A randomized controlled trial with factorial design.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131009014957N8
Enrollment
132
Registered
2019-12-04
Start date
2019-11-22
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Anxiety. Condition 2: Sexual dysfunction. Condition 3: Depression. Condition 4: Serum levels of some bio-markers. Condition 5: Menopausal symptoms. Condition 6: Sleep quality. Other anxiety disorders Sexual dysfunction not due to a substance or known physiological condition Major depressive disorder, single episode Menopausal and other perimenopausal disorders Sleep disorders

Interventions

Intervention 1: Intervention group 1: Mindfulness consulting along with placebo of aroma. Mindfulness in-person counseling will be held once per week for eight weeks through the 45-60 minute sessions

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 60 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study Postmenopausal women between the ages of 50-60 Having read and write literacy The Female Sexual Function Score less than 28 Having mild to moderate anxiety based on Beck Anxiety Scale Having sex in the family limit with her permanent spouse Having only one wife for the man Natural menopause Obtaining a score of 15-42 on the Greene scale Having a score of 5 and higher in The Pittsburgh Sleep Quality Index (PSQI)

Exclusion criteria

Exclusion criteria: Known physical and mental illnesses based on person's self statement (depression, diabetes, cardiovascular disease, olfactory sensations, mental disability, diabetes) Drugs affecting sex (sildenafil, antidepressants, antihistamines, diazepines, barbiturates, amphetamines, antihypertensive drugs, cocaine, thiazide diuretics, narcotics Use of herbal ingredients to increase sexual desire in men or women (ginseng, cinnamon, ginger, etc.) and alergy to any herbal medicine Addiction to the habitual consumption of alcohol and tobacco by women Participate in other similar studies Occurrence of an misadventure within 3 months prior of study (death or acute illness of close relatives) Disorder in the sense of smell according to person's self and other nasal disorders (fracture, aberration, rhinitis) Use of hormotherapy at last 6 month

Design outcomes

Primary

MeasureTime frame
Anxiety score in Beck Anxiety Inventory. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Beck Anxiety Inventory.;Sexual function score in Female Sexual Function Index. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Female Sexual Function Index.;Serum level of cortisol. Timepoint: At baseline and immediately after intervention. Method of measurement: Elisa method by ELISA kits.

Secondary

MeasureTime frame
Depression score using Beck Depression Inventory. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory.;Serum level of malondialdehyde. Timepoint: ?At baseline and immediately after intervention. Method of measurement: By spectrophotometric method based on reaction with thiobarbituric acid.;Serum level of high-sensitivity C-Reactive Protein. Timepoint: ?At baseline and immediately after intervention. Method of measurement: Complex-based turbidometry based on the reaction between high-sensitivity C-Reactive Protein and specific antiserum.;Serum level of Total Antioxidant Capacity. Timepoint: ?At baseline and immediately after intervention. Method of measurement: By Autoanalyzer Abbott (Alcyon 300) using Randox kit.;Frequency of adverse events. Timepoint: While intervention. Method of measurement: Adverse events checklist.;Menopausal symptom score using Greene climacteric scale. Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Greene Climacteric Scale.;The score of Pittsburgh Sleep Quality Index (PSQI). Timepoint: At baseline and 8 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Azizeh Farshbaf-Khalili

Tabriz University of Medical Sciences

farshbafa@tbzmed.ac.ir+98 41 3336 1928

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026