To Assess the Utility of BASNEF Model on the Quality of Life among Peri-menopausal Women

Perimenopausal women are defined as those women who have experienced irregular menses within the last 12 months or the absence of menstrual bleeding for more than three months, but less than 12 months [1]. Post-menopausal health issues has always been given attention, while only few people are aware the health issues associated with peri-menopause. Symptoms include tremendous fluctuations in hormone levels, irregularities in the menstrual cycle, vasomotor and psychological issues [2].

During menopausal transitional phase, women feels little discomfort and some others may have severe and multiple symptoms. Symptoms reported by women have been distributed into several categories, including physical disturbances such as vasomotor symptoms like hot flush, psychological complaints such as mood swings and some other physical symptoms, that may impair personal or social interactions and diminish the overall quality of life among women. These symptoms had a negative effect on the quality of life of the perimenopausal and the post-menopausal women [3]. According to a study conducted on the quality of life among perimenopausal women, those women belonging from local community of Karnataka, shows that physical and psychological symptoms were more common than the vasomotor and sexual symptoms. Researcher concluded that there is need to plan effective intervention to improve quality of life in perimenopausal women [4].

Rationale of study: Climacteric period includes the peri-menopause, Menopause, and postmenopause. During this stages, natural changes of life takes place along with some health problems that occurs like menopausal symptoms, osteoporosis and Coronary Heart Diseases. Researchers give emphasis on the three areas as health promotion, disease prevention and treatment or management [5]. In recent areas, medical professions have been focusing on training and education programme to improve quality of life. During peri-menopause, premenpause and post-menopausal period, women need health care provider for education and awareness to improve their health [6]. Knowledge is an essential requirement to utilise the accessible health services and attitude is an organising principle for doing an action [7].

BASNEF model is one of the comprehensive models that is always used to modify existing behavior into new one. It is based on ‘theory of reasoned action’. This model could improve all aspects of women health, not only by raising awareness and changing patients beliefs and attitudes, but also helps to encourage emotional bonding among people through their participations [8]. One recent study said that, in the present situation BASNEF model is utilised to reduce internet addiction in female students [9]. As there has been no study conducted in India by using BASNEF model, the quality of life of perimenopausal women will be improved with the help of BASNEF model.

Materials and Methods

It is an Interventional analytical study; with the help of two stages cluster sampling technique that will be conducted in rural community settings of two region of the Maharashtra. [Table/Fig-1] shows the schematic diagram of present study.

[Table/Fig-1]:

Flow chart of research design- interventional analytical study. (Nonequivalent control group design).

Inclusion criteria:

The women whose age group between 40 years-55 years.

The women who have husband, friends or family members of perimenopausal women.

All women showing any symptoms of perimenopausal like hot flush, heart discomfort, sleep problems, irritability, physical and mental exhaustion, sexual problems, bladder problems, dryness of vagina, joint and muscular discomfort.

The women are who versed and understand Marathi and Hindi.

Women who are willing to participate in the study.

Exclusion criteria:

Women who were attended psychological counseling and education programme on care during menopause.

Women who have severe mental and physical disability.

Women those who are health professionals.

Womens who are living single (without family as well as friends)

Women want to withdraw from the study.

Not fulfilling study schedule.

Sample size: Sample size has been calculated by using following formula.

The notation for the formula are: n₁=sample size of Group 1; n₂=sample size of Group 2; σ₁=standard deviation of Group 1; σ₂=standard deviation of Group 2; Δ=difference in group means; κ= ratio= n2/n1; Z_1-α/2=two-sided Z value (eg. Z=1.96 for 95% confidence interval);

Z_1-β=power

So, K=1; SD of first group=4.89; SD of second group=4.64. Hence, Δ=9.64-8.22=1.42

Interventions: Intervention will be given to the experimental group and control group will get routine care. [Table/Fig-2] gives details of intervention.

[Table/Fig-2]:

Phases of the intervention of BASNEF Model according to (Belief, Attitude, Subjective Norms, and Enabling Factors).

Phase	Hours	Content of the session
Phase 0:Initial assessment, familiarity with the groups, briefing the study to the groups	Starting sessionDay-01Time-1 hour	Greeting, introducing the session facilitator and womens to each other, and explaining the numbers and the structure of the educational sessions.
		Signing the informed consent form.
		Completing the study instruments and performing the initial measurements. Pre-test will be conducted.
Phase 1: Increasing the knowledge and changing the patient’s behaviors, beliefs and attitudes according to the BASNEF model.	Day-02Time-2 hours	Giving a short lecture on Menopause and lifestyle modification to change the perimenopausal women beliefs and attitude and to motivate them to receive more information on care during menopause.
		Definition and concept of peri-menopause, premenopause and menopause, its causes and contributing factors.
		Explaining the progressive and silent effects of menopause.
		Explaining the effect of symptoms of peri-menopause on the body and quality of life.
		Explaining the care during various symptoms.
		Presenting a list of Investigations to be carried out in Menopause.
		Explaining about the Hormone Replacement Therapy and their advantages and side-effects,
		Explaining importance of diet and exercise in their life to improve quality of life.
		A comparison between lifestyle modification and medical therapy
Phase 2: Behavioural intention in BASNEF model	Day-03Time-2 hours	Dividing the Menopausal behavior and quality of life into smaller components.
		Teaching the perimenopausal womens what behavior is exactly expected of them and how to do it.
		- Teaching the women’s some practical methods of Exercises.
		Teaching the patients some practical stress management methods.
		Explaining the level of appropriate physical activity to reduce and keep the ideal weight considering the body mass index.
		- Presenting the women’s how to stop harmful behaviour, such as lack of exercises, Diet.
		Explaining appropriate diet to get adequate calcium.
Phase 3: Subjective norms in BASNEF model	Day-04Time-1 hour	A meeting will held for people that were significantly effective in the perimenopausal women’s lifestyle such as their spouse, friends children, etc., to discuss on their role in lifestyle and behavior modification and symptoms management and in improving quality of life.
Phase 4: Enabling factors in BASNEF model	During all meetingDay-05Time-1 hour	An educational pamphlet was given to all perimenopausal womens to strengthen and to keep the continuity of the educational training. All patients were informed how to use the services of the healthcare centers and how to receive the necessary care. Also, there will be provision by the researcher’s telephone number to solve their problems and asking their possible questions during the study.
Phase 5: Evaluation	One month and 3 month after the Phase 4	Conducting the post-test (completing the Quality of life questionnaire).

Outcome measures: Primary outcome include assess the utility of BASNEF model on quality of life among perimenopausal women. Secondary outcome include to increase the knowledge, change in belief and attitude, to know participation of subjective norms and to make aware about enabling factors.

Data management and monitoring: The demographic data (age, occupation, education, marital status, types of family), does she know to during menopause and source of information will be recorded, when they enrolled. Baseline Existing Knowledge, Belief, Attitude, Severity of symptoms and quality of life as well as after intervention i.e., at the end of third months of intervention will be recorded.

Statistical Analysis

Statically analyses will be performed using Statistical Package for the Social Sciences (SPSS) software and open epi software. Paired t-test, (Wilcoxon sign Rank) and unpaired t-test (Wilcoxon rank test), Wilcoxon will be used to analyze data within the group. Mann-Whitney test will be applied to see comparison between the groups. ANOVA will be used to see the association with selected demographic variables.

Ethics and disseminations: This study is approved by the Institutional Ethics Committee from DMIMS (DMIMS (DU)/IEC/2018-2019/7346/A).

Results

This study is planned to assess the utility of BASNEF model on the quality of life among perimenopausal women. In this, the study will assess six domains of quality of life. Educational programme based on BASNEF model will improve knowledge about care during menopause. As well as intervention of BASNEF model can improve health promoting behavior and practices. Proper care during peri-menopause may reduce severity of symptoms. With the help of BASNEF model, perimenopausal women will include subjective norms in their care and be aware about enabling factors. If this model proved to be useful in perimenopasual group, then it can be used widely in India on peri-menopause and other conditions.

Conclusion(s)

Conclusion will be drawn after the statistical analysis of result.

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