Climacteric SymptomsNCT07165964
Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric
A study testing Personal interventions in Climateric in people with Climacteric Symptoms and Climactericum, run by University of Barcelona at 1 site in Spain.
Trial summary
This study will test whether a nursing program using podcasts and videos can help women feel better and take better care of themselves during the climacteric (the stage leading up to and following menopause). Read more about this study
- Who is it for?
- Ages 42 to 58 years, women only
- Conditions the study is for
- Climacteric Symptoms, Climactericum, Self Care
- What is being tested?
- Personal interventions in Climateric
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 58 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 42-58 years attending the participating ASSIR centers.
- Clinically identified symptoms of climacteric during routine consultation.
Who cannot join
- Cognitive or learning impairments preventing comprehension of study procedures.
- Physical, emotional, or intellectual limitations hindering completion of study instruments or participation in the intervention.
- Current treatment for hormone dependent cancer.
- Use of an intrauterine device or ongoing hormonal contraceptives.
- Other medical causes of secondary menopause.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Sanchez-Balcells, Sara, Lecturer professor contact
Spain1 site, 1 recruiting
- Recruiting
Universitat de Barceñpma
L'Hospitalet de Llobregat, Barcelona, 08907
Marta Prats,Marta, 934 02 42 56, mprats22@ub.edu
About this study
This study will test whether a nursing program using podcasts and videos can help women feel better and take better care of themselves during the climacteric (the stage leading up to and following menopause). Women between 42 and 58 years old who attend public sexual and reproductive health clinics in the Metropolitan South Health Region of Barcelona (Sant Boi, Sant Feliu, and Cornellà) will be invited to participate.
Participants will be randomly assigned to one of two groups:
Read more
Intervention Group: will receive access to podcasts and videos offering practical advice and strategies to improve emotional well-being and self-care.
Control Group: will receive standard care. All participants will complete questionnaires before and after the program to assess symptoms, mental health, and satisfaction with self-care. Statistical methods will be used to compare the results between both groups and determine whether the program produces a significant difference.
The aim of the study is to demonstrate that this digital nursing intervention is effective and could be implemented more broadly in healthcare settings.
Read the detailed description
Self-Care and Positive Mental Health During the Climacteric Stage: Conceptual Framework and Social Relevance
Self-care is a fundamental human function, particularly vital during the climacteric stage, when women experience significant physical, emotional, and social changes. The conceptual foundation of this project is Dorothea Orem's General Theory of Self-Care Deficit, which encompasses both the individual's capacity for self-care and their ability to care for others. Orem defines self-care as "the personal actions undertaken and performed by each individual to maintain life, health, and well-being, and to consistently respond to their health needs."
Despite the importance of this life stage, the scientific literature indicates that most interventions targeting health issues in women during the climacteric have been non-holistic, often addressing physical and emotional aspects in isolation. There is a notable lack of empirical evidence supporting interventions that simultaneously promote self-care and positive mental health (PMH) in menopausal women. Existing studies tend to focus on problem-solving strategies, lifestyle modifications, and empowerment programs aimed at improving quality of life. However, no specific programs have been identified that address PMH in this population.
Both PMH and self-care capacity are essential constructs for women adapting to the multifaceted changes of the climacteric. Enhancing these dimensions may contribute significantly to health promotion during this extended phase of the female life cycle, which is often marked by conditions that negatively impact quality of life. Research suggests that psychosocial factors such as optimism, emotional stability, and self-esteem are positively associated with well-being and resilience. Moreover, several studies support a bidirectional relationship between self-care and PMH, indicating that improvements in one domain can reinforce the other. A notable example is the PiPsE program, which aims to enhance PMH in individuals with chronic illnesses.
The outcomes of this project are expected to advance the field of women's health by deepening our understanding of the needs of women during the menopausal transition, particularly in relation to PMH and self-care. These findings may inform the development of tailored intervention programs that support women's health across all stages of menopause, aligning with broader health promotion and disease prevention policies.
This proposal aligns with Strategic Line DEM.2.2.4 of the III Strategic Plan for Effective Equality of Women and Men (2022-2025), which advocates for "the implementation of sexual and reproductive health programs at all life stages." By addressing the menopausal stage-a period often overlooked in empirical research-this project contributes to a more comprehensive understanding of women's health. Furthermore, incorporating a gender perspective in health research is essential to correcting and eliminating gender biases in the diagnosis, treatment, and conceptualization of women's physiological and psychological processes. This study promotes a positive, health-affirming approach to women's physical and mental well-being, centering the voices of menopausal women as primary stakeholders.
Utility and Relevance for Social Sectors
This innovative project reorients the focus of women's sexual health from the reproductive phase to its conclusion-menopause-during which women undergo a range of physical, psychoemotional, and social transformations. It is imperative that society recognize and value the resilience and strength of women in this stage, beyond their reproductive roles. Accordingly, this project seeks to highlight women's psychoemotional capacities, self-care abilities, and the broader social significance of these attributes.
It is also essential to provide women with platforms to articulate their physical and emotional needs throughout the climacteric (pre-, peri-, and post-menopause). The findings of this study should inform the design of programs that promote PMH, emotional well-being, and self-care capacity within a health promotion framework, empowering women to take an active role in managing their health. Additionally, this research will help define a distinct domain of women's health, separate from the male sexual and reproductive trajectory.
Evidence continues to show that caregiving responsibilities disproportionately fall on women. As highlighted in the Research Team Experience section, who has long been committed to strengthening the physical and mental resilience of women caregivers through initiatives that promote PMH and self-care. During menopause, many women also assume caregiving roles for elderly dependents, which can exacerbate the physical and emotional challenges of this life stage. This underscores the urgent need to support and reinforce women's self-care-both physical and mental-during the climacteric.
- Conditions
- Climacteric Symptoms, Climactericum, Self Care
- Being tested
- Personal interventions in Climateric
- Keywords
- climateric symptoms, women, climactericum, self care, positive mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal interventions in ClimatericBehavioural
The intervention group (IG) will participate in the climacteric care program. Each participant will receive a personal access code to a Moodle-based virtual campus, where they will find specially designed podcasts and videos, provided in addition to standard care. These digital "pills" have been developed by subject matter experts to support self-care during the climacteric stage and to promote positive mental health (PMH). Each resource is followed by a short quiz to assess engagement, knowledge acquisition, and adherence. A final satisfaction survey will also be included. IG participants will have two months of access to explore the content, complete the quizzes, and interact with the platform.
The intervention includes the following modules:
MODULE 1: INTRODUCTION TO THE CLIMACTERIC/MENOPAUSE MODULE 2: DIETARY HABITS AND PHYSICAL ACTIVITY MODULE 3: PSYCHOEMOTIONAL MANAGEMENT
| Study group | Role | What they receive |
|---|---|---|
| Climateric Intevention Group (IG) | Active comparator | Intervention Group (IG):
Participants will complete the same pre- and post-intervention assessments, including the validated scales and the ad hoc instrument used in the study.
Participants in the intervention group will receive a personal access code to a Moodle virtual campus, where they will find a series of specially designed podcasts and videos addressing self-care during the climacteric and promoting positive mental health (PMH). These digital resources-referred to as "digital pills"-have been developed by experts in the field to meet the specific needs of this population.
Each resource will be followed by a brief quiz to assess participant engagement, knowledge acquisition, and adherence. At the end of the intervention, participants will also complete a satisfaction survey. Access to the platform will remain open for two months, during which participants can view the materials and complete the quizzes at their own pace, alongside receiving usual care. Receives: Behavioral: Personal interventions in Climateric |
| Control Group (CG) | No intervention | Control Group (CG): Participants in the control group will complete the same pre- and post-intervention assessments, including the validated scales and the ad hoc instrument used in the study. The intervention for this group will consist of routine follow-up care provided by a midwife in primary care, focusing on the management of climacteric symptoms. No additional digital resources or structured educational content will be provided beyond standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale
The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.
Measured: Baseline and one month post-intervention
Changes observed in the severity and number of symptoms within the somatic-vegetative, psychological, and urogenital domains during the climacteric.
The level of symptoms associated with the climacteric will be measured using the Menopause Rating Scale (MRS), a validated instrument that assesses the somatic-vegetative, psychological, and urogenital domains. The scale will be administered before and after the intervention to evaluate changes in symptom intensity across these domains.
Measured: Baseline and one month post-intervention
Levels of self-care capacity will be assessed using a validated instrument: the Agency for Self-Care Assessment Scale
The Self-Care Agency Scale (ASA) (Evers and Isenberg, 1989) is a tool designed to assess an individual's overall capacity for self-care. The scale consists of 24 items (16 positive items and 8 negative items), with questions 2, 6, 11, 13, 14, 15, 20 and 23 reverse-scored for the purpose of analysis. The scale utilised is of a Likert-type design, incorporating four possible responses that are tallied for the purpose of analysis. The participants were asked to indicate their level of agreement or disagreement with the following statements using a scale of 1 to 4: 1 = Strongly Disagree, 2 = Disagree, 3 = Agree, 4 = Total Agreement. The results of this study range from 24 (minimum self-care ability) to 96 (maximum self-care ability), thus establishing a cut-off point of <48 to define low self-care ability.
Measured: Baseline and one month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start31 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Climacteric SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model pre-post test in intervention group and pre-post usual follow up in control group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Prats Arimon, University of Barcelona
- Investigators
- Monsterrat Puig-Llobet, Principal investigator, Universitat de Barelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165964
- Sponsor's protocol ID
- IRB00003099 JORDI GOL
- Other IDs
- CER032510
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD when the periode of collecting data is finished.
Publications
Puig Llobet M, Sanchez Ortega M, Lluch-Canut M, Moreno-Arroyo M, Hidalgo Blanco MA, Roldan-Merino J. Positive Mental Health and Self-Care in Patients with Chronic Physical Health Problems: Implications for Evidence-based Practice. Worldviews Evid Based Nurs. 2020 Aug;17(4):293-300. doi: 10.1111/wvn.12453. Epub 2020 Aug 6.
PubMed 32762130Suss H, Willi J, Grub J, Ehlert U. Psychosocial factors promoting resilience during the menopausal transition. Arch Womens Ment Health. 2021 Apr;24(2):231-241. doi: 10.1007/s00737-020-01055-7. Epub 2020 Jul 27.
PubMed 32719937Herson M, Kulkarni J. Hormonal Agents for the Treatment of Depression Associated with the Menopause. Drugs Aging. 2022 Aug;39(8):607-618. doi: 10.1007/s40266-022-00962-x. Epub 2022 Jul 30.
PubMed 35908135Gabes M, Kann G, von Sommoggy J, Stute P, Apfelbacher CJ. 'As long as I have a restroom somewhere [...], I am fine': a qualitative study on the perspectives of peri- and postmenopausal women on the impact of the urinary component of the genitourinary syndrome of menopause (GSM). BMC Womens Health. 2021 Nov 8;21(1):391. doi: 10.1186/s12905-021-01523-x.
PubMed 34743728Khalil J, Boutros S, Kheir N, Kassem M, Salameh P, Sacre H, Akel M, Obeid S, Hallit S. Eating disorders and their relationship with menopausal phases among a sample of middle-aged Lebanese women. BMC Womens Health. 2022 May 10;22(1):153. doi: 10.1186/s12905-022-01738-6.
PubMed 35538474Kafaei-Atrian M, Sadat Z, Nasiri S, Izadi-Avanji FS. The Effect of Self-care Education Based on Self-efficacy Theory, Individual Empowerment Model, and Their Integration on Quality of Life among Menopausal Women. Int J Community Based Nurs Midwifery. 2022 Jan;10(1):54-63. doi: 10.30476/IJCBNM.2021.86814.1370.
PubMed 35005041Carr, A., Cullen, K., Keeney, C., Canning, C., Mooney, O., Chinseallaigh, E., & O'Dowd, A. (2021). Effectiveness of positive psychology interventions: A systematic review and meta-analysis. The Journal of Positive Psychology, 16(6), 749-769. https://doi.org/10.1080/17439760.2020.1818807
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric
- ClinicalTrials.gov ID
- NCT07165964
- Acronym / sponsor ID
- IRB00003099 JORDI GOL
- Conditions
- Climacteric Symptoms, Climactericum, Self Care
- Keywords
- climateric symptoms, women, climactericum, self care, positive mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test whether a nursing program using podcasts and videos can help women feel better and take better care of themselves during the climacteric (the stage leading up to and following menopause). Women between 42 and 58 years old who attend public sexual and reproductive health clinics in the Metropolitan South Health Region of Barcelona (Sant Boi, Sant Feliu, and Cornellà) will be invited to participate.
Participants will be randomly assigned to one of two groups:
Intervention Group: will receive access to podcasts and videos offering practical advice and strategies to improve emotional well-being and self-care.
Control Group: will receive standard care. All participants will complete questionnaires before and after the program to assess symptoms, mental health, and satisfaction with self-care. Statistical methods will be used to compare the results between both groups and determine whether the program produces a significant difference.
The aim of the study is to demonstrate that this digital nursing intervention is effective and could be implemented more broadly in healthcare settings.
Detailed description
Self-Care and Positive Mental Health During the Climacteric Stage: Conceptual Framework and Social Relevance
Self-care is a fundamental human function, particularly vital during the climacteric stage, when women experience significant physical, emotional, and social changes. The conceptual foundation of this project is Dorothea Orem's General Theory of Self-Care Deficit, which encompasses both the individual's capacity for self-care and their ability to care for others. Orem defines self-care as "the personal actions undertaken and performed by each individual to maintain life, health, and well-being, and to consistently respond to their health needs."
Despite the importance of this life stage, the scientific literature indicates that most interventions targeting health issues in women during the climacteric have been non-holistic, often addressing physical and emotional aspects in isolation. There is a notable lack of empirical evidence supporting interventions that simultaneously promote self-care and positive mental health (PMH) in menopausal women. Existing studies tend to focus on problem-solving strategies, lifestyle modifications, and empowerment programs aimed at improving quality of life. However, no specific programs have been identified that address PMH in this population.
Both PMH and self-care capacity are essential constructs for women adapting to the multifaceted changes of the climacteric. Enhancing these dimensions may contribute significantly to health promotion during this extended phase of the female life cycle, which is often marked by conditions that negatively impact quality of life. Research suggests that psychosocial factors such as optimism, emotional stability, and self-esteem are positively associated with well-being and resilience. Moreover, several studies support a bidirectional relationship between self-care and PMH, indicating that improvements in one domain can reinforce the other. A notable example is the PiPsE program, which aims to enhance PMH in individuals with chronic illnesses.
The outcomes of this project are expected to advance the field of women's health by deepening our understanding of the needs of women during the menopausal transition, particularly in relation to PMH and self-care. These findings may inform the development of tailored intervention programs that support women's health across all stages of menopause, aligning with broader health promotion and disease prevention policies.
This proposal aligns with Strategic Line DEM.2.2.4 of the III Strategic Plan for Effective Equality of Women and Men (2022-2025), which advocates for "the implementation of sexual and reproductive health programs at all life stages." By addressing the menopausal stage-a period often overlooked in empirical research-this project contributes to a more comprehensive understanding of women's health. Furthermore, incorporating a gender perspective in health research is essential to correcting and eliminating gender biases in the diagnosis, treatment, and conceptualization of women's physiological and psychological processes. This study promotes a positive, health-affirming approach to women's physical and mental well-being, centering the voices of menopausal women as primary stakeholders.
Utility and Relevance for Social Sectors
This innovative project reorients the focus of women's sexual health from the reproductive phase to its conclusion-menopause-during which women undergo a range of physical, psychoemotional, and social transformations. It is imperative that society recognize and value the resilience and strength of women in this stage, beyond their reproductive roles. Accordingly, this project seeks to highlight women's psychoemotional capacities, self-care abilities, and the broader social significance of these attributes.
It is also essential to provide women with platforms to articulate their physical and emotional needs throughout the climacteric (pre-, peri-, and post-menopause). The findings of this study should inform the design of programs that promote PMH, emotional well-being, and self-care capacity within a health promotion framework, empowering women to take an active role in managing their health. Additionally, this research will help define a distinct domain of women's health, separate from the male sexual and reproductive trajectory.
Evidence continues to show that caregiving responsibilities disproportionately fall on women. As highlighted in the Research Team Experience section, who has long been committed to strengthening the physical and mental resilience of women caregivers through initiatives that promote PMH and self-care. During menopause, many women also assume caregiving roles for elderly dependents, which can exacerbate the physical and emotional challenges of this life stage. This underscores the urgent need to support and reinforce women's self-care-both physical and mental-during the climacteric.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model pre-post test in intervention group and pre-post usual follow up in control group
| Arm | Type | Receives |
|---|---|---|
| Climateric Intevention Group (IG) | Active comparator | Behavioral: Personal interventions in ClimatericIntervention Group (IG): Participants will complete the same pre- and post-intervention assessments, including the validated scales and the ad hoc instrument used in the study. Participants in the intervention group will receive a personal access code to a Moodle virtual campus, where they will find a series of specially designed podcasts and videos addressing self-care during the climacteric and promoting positive mental health (PMH). These digital resources-referred to as "digital pills"-have been developed by experts in the field to meet the specific needs of this population. Each resource will be followed by a brief quiz to assess participant engagement, knowledge acquisition, and adherence. At the end of the intervention, participants will also complete a satisfaction survey. Access to the platform will remain open for two months, during which participants can view the materials and complete the quizzes at their own pace, alongside receiving usual care. |
| Control Group (CG) | No intervention | –Control Group (CG): Participants in the control group will complete the same pre- and post-intervention assessments, including the validated scales and the ad hoc instrument used in the study. The intervention for this group will consist of routine follow-up care provided by a midwife in primary care, focusing on the management of climacteric symptoms. No additional digital resources or structured educational content will be provided beyond standard care. |
Who may qualify
- Ages
- 42 to 58 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 42-58 years attending the participating ASSIR centers.
- Clinically identified symptoms of climacteric during routine consultation.
Key exclusion criteria (5 listed)
- Cognitive or learning impairments preventing comprehension of study procedures.
- Physical, emotional, or intellectual limitations hindering completion of study instruments or participation in the intervention.
- Current treatment for hormone dependent cancer.
- Use of an intrauterine device or ongoing hormonal contraceptives.
- Other medical causes of secondary menopause.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal interventions in ClimatericThe intervention group (IG) will participate in the climacteric care program. Each participant will receive a personal access code to a Moodle-based virtual campus, where they will find specially designed podcasts and videos, provided in addition to standard care. These digital "pills" have been developed by subject matter experts to support self-care during the climacteric stage and to promote positive mental health (PMH). Each resource is followed by a short quiz to assess engagement, knowledge acquisition, and adherence. A final satisfaction survey will also be included. IG participants will have two months of access to explore the content, complete the quizzes, and interact with the platform. The intervention includes the following modules: MODULE 1: INTRODUCTION TO THE CLIMACTERIC/MENOPAUSE MODULE 2: DIETARY HABITS AND PHYSICAL ACTIVITY MODULE 3: PSYCHOEMOTIONAL MANAGEMENT | Behavioural | Climateric Intevention Group (IG) |
Primary outcome
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale
Time frame: Baseline and one month post-intervention
The SMP multifactorial scale consists of 39 items that are distributed among 6 factors: Personal Satisfaction, Prosocial Attitude, Self-Control, Autonomy, Problem Solving and Self-Update, and Interpersonal Relationship Skills. The evaluation of each item is done with a scale scale ranging from 1 to 4. Being 1, always or almost always, 2, quite often, 3 often and 4, never or almost never. Finally, a score between 39 and 156 is obtained, the higher the score the more positive mental health.
Changes observed in the severity and number of symptoms within the somatic-vegetative, psychological, and urogenital domains during the climacteric.
Time frame: Baseline and one month post-intervention
The level of symptoms associated with the climacteric will be measured using the Menopause Rating Scale (MRS), a validated instrument that assesses the somatic-vegetative, psychological, and urogenital domains. The scale will be administered before and after the intervention to evaluate changes in symptom intensity across these domains.
Levels of self-care capacity will be assessed using a validated instrument: the Agency for Self-Care Assessment Scale
Time frame: Baseline and one month post-intervention
The Self-Care Agency Scale (ASA) (Evers and Isenberg, 1989) is a tool designed to assess an individual's overall capacity for self-care. The scale consists of 24 items (16 positive items and 8 negative items), with questions 2, 6, 11, 13, 14, 15, 20 and 23 reverse-scored for the purpose of analysis. The scale utilised is of a Likert-type design, incorporating four possible responses that are tallied for the purpose of analysis. The participants were asked to indicate their level of agreement or disagreement with the following statements using a scale of 1 to 4: 1 = Strongly Disagree, 2 = Disagree, 3 = Agree, 4 = Total Agreement. The results of this study range from 24 (minimum self-care ability) to 96 (maximum self-care ability), thus establishing a cut-off point of <48 to define low self-care ability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Results publication: PubMed 32762130Puig Llobet M, Sanchez Ortega M, Lluch-Canut M, Moreno-Arroyo M, Hidalgo Blanco MA, Roldan-Merino J. Positive Mental Health and Self-Care in Patients with Chronic Physical Health Problems: Implications for Evidence-based Practice. Worldviews Evid Based Nurs. 2020 Aug;17(4):293-300. doi: 10.1111/wvn.12453. Epub 2020 Aug 6.
- Results publication: PubMed 32719937Suss H, Willi J, Grub J, Ehlert U. Psychosocial factors promoting resilience during the menopausal transition. Arch Womens Ment Health. 2021 Apr;24(2):231-241. doi: 10.1007/s00737-020-01055-7. Epub 2020 Jul 27.
- Results publication: PubMed 35908135Herson M, Kulkarni J. Hormonal Agents for the Treatment of Depression Associated with the Menopause. Drugs Aging. 2022 Aug;39(8):607-618. doi: 10.1007/s40266-022-00962-x. Epub 2022 Jul 30.
- Results publication: PubMed 34743728Gabes M, Kann G, von Sommoggy J, Stute P, Apfelbacher CJ. 'As long as I have a restroom somewhere [...], I am fine': a qualitative study on the perspectives of peri- and postmenopausal women on the impact of the urinary component of the genitourinary syndrome of menopause (GSM). BMC Womens Health. 2021 Nov 8;21(1):391. doi: 10.1186/s12905-021-01523-x.
- Results publication: PubMed 35538474Khalil J, Boutros S, Kheir N, Kassem M, Salameh P, Sacre H, Akel M, Obeid S, Hallit S. Eating disorders and their relationship with menopausal phases among a sample of middle-aged Lebanese women. BMC Womens Health. 2022 May 10;22(1):153. doi: 10.1186/s12905-022-01738-6.
- Results publication: PubMed 35005041Kafaei-Atrian M, Sadat Z, Nasiri S, Izadi-Avanji FS. The Effect of Self-care Education Based on Self-efficacy Theory, Individual Empowerment Model, and Their Integration on Quality of Life among Menopausal Women. Int J Community Based Nurs Midwifery. 2022 Jan;10(1):54-63. doi: 10.30476/IJCBNM.2021.86814.1370.
- Results publicationCarr, A., Cullen, K., Keeney, C., Canning, C., Mooney, O., Chinseallaigh, E., & O'Dowd, A. (2021). Effectiveness of positive psychology interventions: A systematic review and meta-analysis. The Journal of Positive Psychology, 16(6), 749-769. https://doi.org/10.1080/17439760.2020.1818807
- Individual participant dataSharing planned: Yes. All collected IPD when the periode of collecting data is finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Sanchez-Balcells, Sara, Lecturer professor contact
Monsterrat Puig-Llobet principal investigator
Universitat de Barelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal interventions in Climateric in people with Climacteric Symptoms and Climactericum, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monste Puig-Llobet, Monsterrat, Professor (934 02 42 56, monpuigllob@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale (time frame: Baseline and one month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165964, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.