Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric

NCT07165964 | Recruiting

• 2 other identifiers: IRB00003099 JORDI GOLCER032510
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Climacteric Symptoms; Climactericum; Self Care

Keywords

climateric symptoms; women; climactericum; self care; positive mental health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and one month post-intervention

Study Arms (2)

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.

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.

Interventions

Personal interventions in Climateric BEHAVIORAL

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

Climateric Intevention Group (IG)

Eligibility Criteria

• Age: 42 Years - 58 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 42-58 years attending the participating ASSIR centers.
• Clinically identified symptoms of climacteric during routine consultation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Universitat de Barceñpma

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 32762130 RESULT

• Suss 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.

  PMID: 32719937 RESULT

• Herson 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.

  PMID: 35908135 RESULT

• Gabes 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.

  PMID: 34743728 RESULT

• Khalil 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.

  PMID: 35538474 RESULT

• Kafaei-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.

  PMID: 35005041 RESULT

• Carr, 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

  RESULT

Study Officials

• Monsterrat Puig-Llobet

  Universitat de Barelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monste Puig-Llobet, Monsterrat, Professor

CONTACT

934 02 42 56; monpuigllob@ub.edu

Sara Sanchez-Balcells, Sara, Lecturer professor

CONTACT

sara.sanchez@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigador

Model Details: Model pre-post test in intervention group and pre-post usual follow up in control group

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 10, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start in september 2025 until desember 2025
• Access Criteria: All team researchers from University of Barcelona can share IPD throught SPSS program by corporative mail.All researchers need a password to access the institution's intranet. In addition, a shared folder will be generated where only researchers have access to share other documents.

Locations

ES (1)