Online Cognitive Awareness-Based Nursing Support for Premenopausal

NCT06196372 | Completed

• 1 other identifier: BandırmaOnyediEylulU-FAD-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study was conducted at Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between 16.05.2022-30.06.2023. Research data were collected at the gynecology outpatient clinic. The sample of the study consisted of 74 (37-intervention, 37-control) premenopausal women who met the inclusion criteria and were placed by randomization. The data of the study were collected using "Personal Information Form, Mindful Attention Awareness Scale (MAAS), Visual Analogue Scale for Vasomotor Symptoms (VAS), Perceived Stress Scale (PSS) and Menopause-Specific Quality of Life Scale (MENQOL)". First, the pretests of the study were applied to women in the intervention and control groups. Afterwards, women in the intervention group underwent the MenoMind program for eight weeks, and women in the control group were left with routine clinical care. In the eighth week of the research, the "MenoMind Evaluation Form" was applied to the women in the intervention group to evaluate the MenoMind program. One month after the study was completed, post-tests were performed on the intervention and control groups.

Conditions

Pre-Menopause; Irregular Menstruation

Keywords

Pre-menopause,; Mindfulness; Vasomotor; Stress; Quality of life

Outcome Measures

Primary Outcomes (1)

• Personal Information Form

  The personal information form, created in line with the literature, aims to determine the socio-demographic characteristics of women in the premenopausal period; It is a form consisting of 13 items containing descriptive information specific to the individual (age, education, marital status, employment status, income level, vasomotor symptoms, smoking status and regular exercise status).

  5th minute

Secondary Outcomes (4)

• Mindful Attention Awareness Scale (MAAS)

  5th minute

• Visual Analog Scale for Vasomotor Symptoms (VAS)

  2th minute

• Perceived Stress Scale (PSS)

  5th minute

• Menopause-Specific Quality of Life Scale (MENQOL)

  10th minute

Study Arms (2)

Experimental: Intervention

EXPERIMENTAL

An online mindfulness nursing support program (MenoMind) was applied to this group for 8 weeks and lasting an average of 50 minutes.

Other: MenoMind intervention group

Control

NO INTERVENTION

The control group received no intervention and the women were left to routine clinical care.

Interventions

MenoMind intervention group OTHER

To implement the MenoMind program, the women in the initiative group were divided into groups of 4-5 according to their convenient days and hours, and it was done via the Zoom© program. MenoMind program was carried out via video on WhatsApp© program for women who could not or did not want to use the Zoom© program. The researcher provided support to the women for eight weeks, in different groups, 2-3 days a week and at different times, depending on their availability. Each session is approximately 50 minutes. lasted. In addition, make-up sessions were organized for women who could not attend the sessions for various reasons or had difficulty complying with the program (day/date).

Experimental: Intervention

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: The groups were created by women in the premenopausal period.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being able to read and write,
• Being able to use the internet,
• Having a device that can use the internet (such as a smartphone or computer),
• Not having a diagnosed psychiatric disease,
• Not having a chronic disease
• Not using hormone replacement therapy,
• Age 40 and above and having symptoms of menstrual irregularity,
• Receiving an average score of two or more from Menopause-Specific Quality of Life Scale,
• Scoring three or more on the Visual Analogue Scale for Vasomotor Symptoms

You may not qualify if:

• There are situations that prevent the exercises from being performed,
• Participating in a mindfulness training program before.

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Hospital between

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatma Aslan Demirtaş, Msc

  Bandırma Onyedi Eylül University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The design of this study is a randomized controlled experimental study with a single-blind pretest-posttest control grou

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: May 16, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 12, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)