Nursing Interventions to Enhance Positive Mental Health and Self Care in Women During the Climacteric
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age42-58
SponsorUniversity of Barcelona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 42-58 years attending the participating ASSIR centers.
Clinically identified symptoms of climacteric during routine consultation.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Personal interventions in Climateric
BehavioralThe 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
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Climateric Intevention Group (IG)Active comparator 1 intervention
Group B: Control Group (CG)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and one month post-intervention2
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.
Time frame
Baseline and one month post-intervention3
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.
Time frame
Baseline and one month post-interventionSponsors and contacts
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Source ClinicalTrials.gov