Effect of Lavender Versus Primrose Oil on Menopause Symptom

August 11, 2023 updated by: Fatma Zaghloul, Cairo University

Effect of Primrose Oil Versus Lavender Oil on Hot Flashes and Night Sweats Among Menopausal Women

there is a scanty of researches which integrate to investigate the comparing effect of evening primrose oil and lavender as the essential oil that affects on menopausal vasomotor symptoms especially hot flashes and night sweet Therefore, the current study is expected to contribute to the knowledge and practice regarding the effect of lavender versus primrose oil on hot flashes and night sweat in menopausal women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to assess the efficacy of primrose oil versus lavender oil on hot flashes and night sweats among menopausal women

Research Hypotheses To fulfill the aim of this study the following research hypotheses will be formulated H1: Menopausal women who will receive evening primrose oil may show decrease in frequency and severity of hot flashes and night sweat as compared to those who will receive routine care H2: Menopausal women who will receive lavender oil may show decrease in frequency and severity of hot flashes and night sweat as compared to those who will receive routine care H3: There is a difference between menopausal women who will receive evening primrose oil versus lavender oil in relation to frequency and severity of hot flashes and night sweat Outcome measures

Sample A total of (150) menopausal women who will attend the out patient gynaecological clinic at Obstetrics and Gynecological hospital in Cairo university hospitals, Kasr El Ainy will be recruited for this study and randomly assigned to either group who will receive primrose oil (50) women, the other group who will receive lavender oil (50) women, the placebo group (50) who will take package of oil but dosnt contain the active substance .

Tools for Data Collection To fulfill the aim of the study fourth tools will be utilized for data collection. The first one the interviewing questionnaire which was designed by the researcher through extensive review of literature; the second tool is Daily hot flash / night sweets diaries; the third tool is Hot-flush/ night sweet problem-rating (HFNS Problem Rating) and the fourth tool is Hot Flash Related Daily Interference Scale (HFRDIS).

Tools used in the Randomized Control Trail:

First tool: Interviewing Questionnaires Schedule (Appendix A) This tool designed by the researcher after extensive literature review which constituted of four parts; first part data related to demographic characteristics such as age, level of education, residence and occupation. Second part data related to menstrual history and menopausal status.

Second tool: Daily hot flash / night sweets diaries Daily Hot Flash Diary: It is a selfreport dairy , in which participants recorded how many hot flashes they experienced on a daily basis as well as the severity of each hot flash on a scale of 1-3 (1 being mild, 2 moderate, and 3 severe). Hot flashes throughout a 7-day period were added to produce a weekly hot flash frequency score. While the number of hot flashes reported in each severity level was used to calculate the daily severity score, the total number of daily severity scores over the course of seven days was used to determine the hot flash severity index The hot flash severity score for each day was calculated as the sum of the number of hot flashes within each severity category, multiplied by the severity score for that category, with the resulting sum divided by the total number of hot flashes Third tool: Hot-flush/ night sweet problem-rating (HFNS Problem Rating) This tool is standardized tool to measure the extent to which HFNS are a problem, it is a subscale of the Hot Flush Rating Scale (HFRS) this validated self-report measure has three questions using 10-point Likert scales to rate the extent to which HFNS are problematic, distressing, and the cause of interference in daily life. Problem rating is calculated as the mean of the three questions, with higher scores indicating more problematic. This tool has significant correlations with diary recordings for hot flushes (r=0.97, p<0.001) and night sweats (r=0.94, p<0.001). HFRS has good test-retest reliability (r=0.8) and internal consistency (alpha=0.87); the internal reliability alpha coefficients 0.84. it is significantly associated (r=0.61-0.85 p<0.001) .

Fourth tool: Hot Flash Related Daily Interference Scale (HFRDIS) It is a 10-item scale to assess the degree to which hot flashes interfere with women's daily life activities. The first nine items assess the quality of daily life activities including work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, and enjoyment of life and the tenth item assesses the overall quality of life. On a scale of 0 (do not interfere) to 10 (totally interfere), Women rate the extent to which hot flashes interfered with each item throughout the previous week. A total score is calculated by summing items. Higher scores reflect more interference from hot flashes and a greater impact on quality of life. The total score ranges from 0-100. This score was interpreted to the Mild interference 0-33•corresponding daily interference as follows: Moderate interference 34-67• Severe interference 68-100• Validity and reliability

Tools of data collection are standardized tool..UN standardized tools were submitted to 3 experts in the field of maternity nursing to test content validity, clarity of sentences and an appropriateness of content. Modifications were carried out according to the expert judgment before seeking the acceptance of ethical committee.

Ethical consideration An official approval to conduct the proposed study will be obtained from the Research Ethics Committee at faculty of nursing - Cairo University. As well, an official permission will be taken from the administrative personnel in the recommended settings. Also, each woman will be informed orally about the purpose of the trial and its importance. In addition, informed written consent will be obtained from women who will be willing to participate in the trial after ensuring that their participation in the trial will be voluntary and can be withdrawing at any time. As well as the anonymity, confidentiality and privacy of the information will be maintained.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12519
        • Faculty of nursinf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • can read and write
  • experienced amenorrhea for > 6 months
  • mild or moderate-to-severe hot flashes at least twice daily
  • normal blood pressure
  • normal kidney and liver function
  • no abnormal vaginal bleeding
  • no sensitivity to herbal substances

Exclusion Criteria:

  • Women with serious disease such as kidney, liver, seizure and allerg
  • use of hormonal medications or herbal treatment in the preceding 2 months for treatment of hot flushes or night sweet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: primrose oil
Other: Primrose oil
group A will take primrose oil
Experimental: lavender oil
Other: Lavender oil
group B will take lavender oil
Placebo Comparator: the placebo group
took the same bottle of oil which didn't contain the active substances but have the same shape, same oder, same color.
Other: placcebo
this is the comparator group who will take the same bottle of oil which dosnt contain the active substances but have the sampe shape, same oder, same color

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of hot flashes among menopausal women.
Time Frame: Before intervention, 4 week after intervention, 8 week after intervention
it will be assessed by Daily Hot Flash Diary: It is a selfreport dairy in which participants recorded how many hot flashes they experienced on a daily basis. Hot flashes throughout a 7-day period were added to produce a weekly hot flash frequency score
Before intervention, 4 week after intervention, 8 week after intervention
severity of hot flashes among menopausal women
Time Frame: Before intervention, 4 week after intervention, 8 week after intervention

it will be assessed by Daily Hot Flash Diaryas well as the severity of each hot flash on a scale of 1-3 (1 being mild, 2 moderate, and 3 severe). the number of hot flashes reported in each severity level was used to calculate the daily severity score, the total number of daily severity scores over the course of seven days was used to determine the hot flash severity index.

The hot flash severity score for each day was calculated as the sum of the number of hot flashes within each severity category, multiplied by the severity score for that category, with the resulting sum divided by the total number of hot flashes
Before intervention, 4 week after intervention, 8 week after intervention
to To what extent hot flash and night sweet are a problem
Time Frame: Before intervention, 4 week after intervention, 8 week after intervention
This tool is standardized tool to measure the extent to which hot flash and night sweet are a problem, it is a subscale of the Hot Flush Rating Scale (HFRS) this validated self-report measure has three questions using 10-point Likert scales to rate the extent to which HFNS are problematic, distressing, and the cause of interference in daily life. Problem rating is calculated as the mean of the three questions, with higher scores indicating more problematic
Before intervention, 4 week after intervention, 8 week after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hot Flash Related Daily Interference
Time Frame: Before intervention, 4 week after intervention, 8 week after intervention
It is a 10-item scale developed by Carpenter, (2001) to assess the degree to which hot flashes interfere with women's daily life activities. The first nine items assess the quality of daily life activities including work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, and enjoyment of life and the tenth item assesses the overall quality of life. On a scale of 0 (do not interfere) to 10 (totally interfere), Women rate the extent to which hot flashes interfered with each item throughout the previous week. A total score is calculated by summing items. Higher scores reflect more interference from hot flashes and a greater impact on quality of life. The total score ranges from 0-100. This score was interpreted to the Mild interference 0-33•corresponding daily interference as follows: Moderate interference 34-67• Severe interference 68-100•
Before intervention, 4 week after intervention, 8 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Lamiaa Saad, lecturer, Faculty of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Lavender and Primrose

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the data will be shared online

IPD Sharing Time Frame

four month

IPD Sharing Access Criteria

will be published on magazine

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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