Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605742
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-05-22
Brief Title:
The Effect of Counseling Based on the Roy Adaptation Model on Sexual Life and Quality of Life in Menopause
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of The Support and Counseling Program Based on the Roy Adaptation Model in Postmenopausal Women With Genitourinary Syndrome
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study it was aimed to determine the effect of the support and counseling program based on the Roy Adaptation Model given to postmenopausal women with Genitourinary Syndrome on their sexual life and quality of life
Detailed Description:
Menopause one of the important stages of a womans life is a gradual physiological change process that occurs simultaneously with age and developmental changes According to the 2018 data of the Turkish Statistical Institute TUIK the average life expectancy for women is 807 years With the prolongation of life expectancy the number of women in the menopause period increases and women spend 13 of their lives in the menopause period By 2030 the global population of menopausal women is expected to include 12 billion people Menopause which has an important place in a womans life has become one of the important womens health problems that should be considered in health service planning and delivery
Menopause is defined as the permanent cessation of menstruation due to the absence of estrogen production from the ovaries Estrogen deprivation that occurs during this period causes the emergence of various signs and symptoms that have a significant impact on quality of life physical mental and sexual health As a result of hormonal deprivation and aging the anatomy and function of the urogenital tissues are significantly affected and vulvovaginal atrophy may occur The terms vulvovaginal atrophy and atrophic vaginitis were found to be insufficient to describe menopausal symptoms associated with changes in the vulva vagina and lower urinary tract due to estrogen deficiency and the term Genitourinary Syndrome in Menopause MGS was developed for a more inclusive terminology
MGS is defined as the sum of symptoms and signs associated with a decrease in estrogen and other sex steroids including changes in the labia majorminor clitoris vestibule vagina urethra and bladder The prevalence of MGS is 70 and causes vaginal dryness irritationburningitching in the vulva or vagina decreased lubrication during sexual activity dyspareunia postcoidal bleeding frequent urination and urinary incontinence Srisukho et al 2019 conducted among Thai postmenopausal women the most common symptoms were found to be nocturia 777 and vaginal dryness 517 Moral et al 2018 found that postmenopausal women most commonly experience vaginal dryness 933 and decreased lubrication in sexual activity 900 Selvi et al 2020 similarly found that postmenopausal women most commonly experienced vaginal dryness 662 decreased lubrication 553 urgency 548 and urinary incontinence 392 Although these complaints negatively affect the daily life activities quality of life and sexual health of postmenopausal women women do not share their complaints with health care providers and often believe that they are a natural part of aging Only 6-7 of postmenopausal women are treated MGS associated with menopause and aging is usually permanent unlike menopausal symptoms that disappear from time to time such as hot flashes but most women have no knowledge of the causes and effects of this condition In the Vaginal Health Perceptions Perceptions and Attitudes VIVA survey 55 of women with vaginal conditions reported experiencing symptoms for 3 years or more and only a minority 4 attributed their symptoms to MGS Age attitudes towards menopause sexual activity chronic diseases biopsychosocial reasons affect the level of MGS-related problems and the rate of seeking treatment Chua et al 2017 in a study conducted in five European countries the rate of referral to healthcare professionals with the complaint of MGS was found to be in Asia 25 the United States 56 and Europe 62 MGS is an under-recognized medical problem by healthcare providers and under-reported by women Therefore recent research suggests that healthcare providers should be proactive in helping their patients explain symptoms related to MGS Most women expect their healthcare providers to initiate conversations about MGS complaints Several studies of women with self-reported MGS symptoms have shown that poor MGS management may be the result of poor awareness reluctance to seek timely medical advice and lack of communication between healthcare professionals
Early recognition of signs and symptoms of MGS provision of communication tools to facilitate dialogue development of patient-based education programs and individual counseling are the basic steps that will help women to protect their sexual health and quality of lifeWhile preparing the consultancy program its preparation in accordance with the conceptual and theoretical framework will facilitate the execution and monitoring of the service In this respect the Roy Adaptation Model RAM supports the adaptation process of women with MGS complaints According to RAM adaptation is a set of processes in which an individual responds to environmental changes or stimuli RAM examines stimuli in three groups as both internal and external factors focal stimuli are the focal stimuli that directly cause the adaptive response to which the individual immediately responds contextual stimuli are all other stimuli that contribute to the effect of the focal stimulus All stimuli that are not the direct cause of the behavior but affect the behavior and can be measured residual stimuli They are stimuli that can affect the individual but cannot be measured objectively The person may not be aware of this factor or the effect of the factor may not be observed Stimuli from the internal and external environment in turn activate regulatory and cognition coping mechanisms that generate behavioral responses related to physiological self-concept role function and interdependence The response of the individual occurs as a result of the stimulus and the level of adaptation As a result the individual exhibits adaptive behavior that maintains its integrity or ineffective negative behavior If a person constantly adapts the result is health and if the coping mechanism is insufficient the result is disease The goal of nursing interventions in RAM is to increase adaptive responses in each of the four adaptive domains in health and disease states According to Roy the four adaptive domains are independent of each other At the same time they have an impressive and integrating feature A change in any of these adaptive areas causes changes in other areas Roy Adaptation Model considers healthy and sick individuals as a whole with their physiological psychological and social aspects The models use of the method of recognizing the individual in all aspects facilitates nursing interventions
RAM is widely used as a conceptual model to guide education research practice and knowledge development Elmoneim et al 2017 found that a training program based on the Roy Adaptation Model had a positive effect on sexual function and spousal support among women with total hysterectomy In a study conducted with a group of women in the menopausal period it was found that the Roy Adaptation Model guides the assessment of womens adaptation levels and facilitates the management of stimuli to promote their adaptation providing a holistic approach to evaluate and analyze the menopausal transition In this context it can be said that providing consultancy in accordance with the RAM model will increase the effectiveness of the consultancy service
There are a limited number of studies on the implementation of training and consultancy for MGS in our country As a result the need for education and counseling is inevitable when the prevalence of MGS and the negative effects of the complaints on womens quality of life and sexual life are considered It is thought that the counseling program based on the Roy Adaptation Model to be given to women suffering from MGS will contribute to the quality of life and sexual life of women The educational content to be created with this study will form a direction for future studies and the materials booklet etc to be prepared will serve as a resource for health professionals Visibility of the problem and awareness of MGS will be provided and it will guide future researches This study will contribute to the literature by examining the effect of the Roy Adaptation Model-based counseling program given to women with MGS complaints on their sexual life and quality of life
Menopause is defined as the permanent cessation of menstruation due to the absence of estrogen production from the ovaries Estrogen deprivation that occurs during this period causes the emergence of various signs and symptoms that have a significant impact on quality of life physical mental and sexual health As a result of hormonal deprivation and aging the anatomy and function of the urogenital tissues are significantly affected and vulvovaginal atrophy may occur The terms vulvovaginal atrophy and atrophic vaginitis were found to be insufficient to describe menopausal symptoms associated with changes in the vulva vagina and lower urinary tract due to estrogen deficiency and the term Genitourinary Syndrome in Menopause MGS was developed for a more inclusive terminology
MGS is defined as the sum of symptoms and signs associated with a decrease in estrogen and other sex steroids including changes in the labia majorminor clitoris vestibule vagina urethra and bladder The prevalence of MGS is 70 and causes vaginal dryness irritationburningitching in the vulva or vagina decreased lubrication during sexual activity dyspareunia postcoidal bleeding frequent urination and urinary incontinence Srisukho et al 2019 conducted among Thai postmenopausal women the most common symptoms were found to be nocturia 777 and vaginal dryness 517 Moral et al 2018 found that postmenopausal women most commonly experience vaginal dryness 933 and decreased lubrication in sexual activity 900 Selvi et al 2020 similarly found that postmenopausal women most commonly experienced vaginal dryness 662 decreased lubrication 553 urgency 548 and urinary incontinence 392 Although these complaints negatively affect the daily life activities quality of life and sexual health of postmenopausal women women do not share their complaints with health care providers and often believe that they are a natural part of aging Only 6-7 of postmenopausal women are treated MGS associated with menopause and aging is usually permanent unlike menopausal symptoms that disappear from time to time such as hot flashes but most women have no knowledge of the causes and effects of this condition In the Vaginal Health Perceptions Perceptions and Attitudes VIVA survey 55 of women with vaginal conditions reported experiencing symptoms for 3 years or more and only a minority 4 attributed their symptoms to MGS Age attitudes towards menopause sexual activity chronic diseases biopsychosocial reasons affect the level of MGS-related problems and the rate of seeking treatment Chua et al 2017 in a study conducted in five European countries the rate of referral to healthcare professionals with the complaint of MGS was found to be in Asia 25 the United States 56 and Europe 62 MGS is an under-recognized medical problem by healthcare providers and under-reported by women Therefore recent research suggests that healthcare providers should be proactive in helping their patients explain symptoms related to MGS Most women expect their healthcare providers to initiate conversations about MGS complaints Several studies of women with self-reported MGS symptoms have shown that poor MGS management may be the result of poor awareness reluctance to seek timely medical advice and lack of communication between healthcare professionals
Early recognition of signs and symptoms of MGS provision of communication tools to facilitate dialogue development of patient-based education programs and individual counseling are the basic steps that will help women to protect their sexual health and quality of lifeWhile preparing the consultancy program its preparation in accordance with the conceptual and theoretical framework will facilitate the execution and monitoring of the service In this respect the Roy Adaptation Model RAM supports the adaptation process of women with MGS complaints According to RAM adaptation is a set of processes in which an individual responds to environmental changes or stimuli RAM examines stimuli in three groups as both internal and external factors focal stimuli are the focal stimuli that directly cause the adaptive response to which the individual immediately responds contextual stimuli are all other stimuli that contribute to the effect of the focal stimulus All stimuli that are not the direct cause of the behavior but affect the behavior and can be measured residual stimuli They are stimuli that can affect the individual but cannot be measured objectively The person may not be aware of this factor or the effect of the factor may not be observed Stimuli from the internal and external environment in turn activate regulatory and cognition coping mechanisms that generate behavioral responses related to physiological self-concept role function and interdependence The response of the individual occurs as a result of the stimulus and the level of adaptation As a result the individual exhibits adaptive behavior that maintains its integrity or ineffective negative behavior If a person constantly adapts the result is health and if the coping mechanism is insufficient the result is disease The goal of nursing interventions in RAM is to increase adaptive responses in each of the four adaptive domains in health and disease states According to Roy the four adaptive domains are independent of each other At the same time they have an impressive and integrating feature A change in any of these adaptive areas causes changes in other areas Roy Adaptation Model considers healthy and sick individuals as a whole with their physiological psychological and social aspects The models use of the method of recognizing the individual in all aspects facilitates nursing interventions
RAM is widely used as a conceptual model to guide education research practice and knowledge development Elmoneim et al 2017 found that a training program based on the Roy Adaptation Model had a positive effect on sexual function and spousal support among women with total hysterectomy In a study conducted with a group of women in the menopausal period it was found that the Roy Adaptation Model guides the assessment of womens adaptation levels and facilitates the management of stimuli to promote their adaptation providing a holistic approach to evaluate and analyze the menopausal transition In this context it can be said that providing consultancy in accordance with the RAM model will increase the effectiveness of the consultancy service
There are a limited number of studies on the implementation of training and consultancy for MGS in our country As a result the need for education and counseling is inevitable when the prevalence of MGS and the negative effects of the complaints on womens quality of life and sexual life are considered It is thought that the counseling program based on the Roy Adaptation Model to be given to women suffering from MGS will contribute to the quality of life and sexual life of women The educational content to be created with this study will form a direction for future studies and the materials booklet etc to be prepared will serve as a resource for health professionals Visibility of the problem and awareness of MGS will be provided and it will guide future researches This study will contribute to the literature by examining the effect of the Roy Adaptation Model-based counseling program given to women with MGS complaints on their sexual life and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None