Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
250
Sex
Women only
Ages
Ages 42 Years to 58 Years
Primary completion
2026-07-01
Last update
2026-02-05

What this trial studies

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.

Conditions in scope

  • Climacteric Symptoms
  • Climactericum
  • Self 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…

Who can join

Women only · Ages 42 Years to 58 Years

Inclusion criteria

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

Exclusion criteria

  • 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 wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

CityState / RegionFacilitySite status
L'Hospitalet de Llobregat Barcelona Universitat de Barceñpma Recruiting

Status & timeline

  • Overall status: Recruiting
  • Study type: Interventional
  • Phase: N/A
  • Start date: 2025-07-31
  • Primary completion: 2026-07-01
  • Last update posted: 2026-02-05
  • First posted: 2025-09-10

Lead sponsor: University of Barcelona (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

  • Change from baseline of positive mental health on 39 points of the Positive Mental Health Scale (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…
  • Changes observed in the severity and number of symptoms within the somatic-vegetative, psychological, and urogenital domains during the climacteric. (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 (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…

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Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07165964 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.