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.

Determination of effect of 8 weeks intervention with lavender-bergamot aroma, mindfulness counseling, aroma-mindfulness counseling on sexual function score, anxiety score, and levels of some serum bio-markers in postmenopausal women compared to control group

A randomized controlled clinical trial with a factorial design, stratified by menopause duration. 132 postmenopausal women randomly will be divided into four groups of counseling based on mindfulness and aroma placebo, aromatherapy and routine care, counseling based on mindfulness and aromatherapy, and control group using Random Allocation Software (RAS) with 1:1:1:1 ratio.

Eligible women will be selected among health centers and randomly assigned into one of the four groups after giving written informed consent. Aroma and its similar placebo, 3 times daily, 2-3 drops on the skin for 8 weeks and counseling in 45-60 minutes sessions, once a week for 8 consecutive weeks will be administered.The blinding of researcher and participants in terms of counseling will not be possible

Inclusion criteria: Married postmenopausal women; Age between 50-60; Having records in Tabriz Elderly Friendly Centers; Mild to moderate anxiety; Sexual dysfunction score less than 28; PSQI 5 or more; Greene between 15-42. Exclusion criteria: Use of herbal compounds to increase libido in men or women; Sensitivity to any of the herbal remedies; Occurrence of the adverse event within 3 months prior to the study;

The groups receiving counseling based on mindfulness and aromatherapy, aromatherapy and routine care, counseling based on mindfulness and aromatherapy, or control group (placebo of aroma and routine care)

Mean score of sexual function after intervention Mean score of anxiety after intervention Serum level of some bio-markers after intervention

Hi, ]t is hereby conveyed that due to the coincidence of the implementation stages of this trial with the corona pandemic and its various peaks, the sampling process was prolonged and sampling was completed with a delay on 2020-11-21 instead of 2020-03-15. Therefore, we want to correct the completion date of sampling. Also, along with the studied variables, due to the importance of sleep quality and menopausal symptoms in menopausal women, these two variables were also considered as a secondary outcome along with other variables. Therefore, please agree with the above amendments. Thank you

Postmenopausal women aged 50-60 years will be divided into four groups of aromatherapy and routine care, counseling based on Mindfulness-Based Intervention (MBI) and aromatherapy, counseling based on MBI and placebo of aromatherapy, and control group (placebo of aromatherapy and routine care) using the RAS software with four and eight blocks with a 1: 1: 1: 1 allocation ratio and will be stratified based on menopausal years (less than or greater than 5 years). To conceal the allocated intervention, type of counseling intervention (counseling or routine care) will be written on papers and along with allocated aromas or placebo will be placed in the matte and sealed envelopes numbered from 1 to 132 based on random sequence generated by a non-researcher. The first envelope will be given to the first eligible person and will be continued until the completion of sampling. The participant, researcher and statistical analyst will not be aware of the contents of the package (allocation concealment). In this study, after the random allocation of the individual to the study group, the researcher and participant blindness would not be possible in terms of counseling,

In this study, outcome assessor and statistical analyst will be kept blind to the specific study groups. So that the combined aroma and its placebo will be poured into identical dark containers and identified only by random code of study. The outcome assessor and the statistical analyst will not be present at the consultation sessions. Questionnaires will not specify the type of intervention and only random code will be written. Also in the statistical software, only the code of the participants and the group number will be written.

Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis).

ُStarting immediately after publication

Data will be available to researchers as well as to journals

The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking

Refer to the email address (farshbafa@tbzmed.ac.ir)

The requests will be sent by email and data will be available within a week