The Effect of Mindfulness-Based Lifestyle Support Program on Infertile Women

NCT06799507 | Recruiting

• 1 other identifier: DEU-HF-FY-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial aimed to determine whether a mindfulness-based lifestyle support program would improve quality of life, lifestyle, mindfulness, attention and meditation level and treatment outcomes in women undergoing IVF treatment.

Conditions

Fertility Disorders; Infertility (IVF Patients)

Keywords

Infertility; Mindfulness; Quality of Life; Life Style

Outcome Measures

Primary Outcomes (2)

• The Fertility Quality of Life

  Fertility quality of life tool (FertiQoL): This scale is a self-rating questionnaire specifically designed to assess the quality of life of infertile patients. It has good reliability and efficacy in many countries. The Cronbach's α value of the Turkish version of FertiQoL is 0.905. The FertiQoL scale includes two modules: The Core FertiQoL module and the optional Treatment FertiQoL module. The Core FertiQoL module is divided into four domains: emotional (6 items), mind-body (6 items), relationship (6 items) and social (6 items). The optional Treatment FertiQoL module is divided into two domains: environment (6 items) and tolerability of infertility treatment (4 items). Each item has a score of 0-4 points and the total scale and subscale scores can be converted into 0-100 point scales. The higher the scores obtained from the scale, the higher the fertility-related quality of life.

  through study completion, average 28 days

• Fertility Healthy Lifestyle

  Fertility Healthy Lifestyle Assessment Scale (FHLAS): This is a 46-item scale developed by Bilgiç et al. to assess healthy lifestyles that contribute to improving fertility in women and men. It consists of seven sub-dimensions and is a 5-point Likert-type scale (1-strongly disagree, 2- disagree, 3 undecided, 4- agree, and 5-strongly agree). The seven sub-dimensions of the scale are emotional well-being, physical activity, sleep, nutrition, technology, hygiene and spirituality. Cronbach's Alpha value of the scale was found to be 0.87. The lowest score obtained from the scale is 46 and the highest score is 230. High scores obtained from the total scale and its sub-dimensions indicate that individuals have a lifestyle associated with healthier fertility.

  through study completion, average 28 days

Secondary Outcomes (5)

• Mindfulness

  through study completion, average 28 days

• Attention and Meditation Level

  through study completion, average 28 days

• Treatment Outcome-Number of Embryos

  through study completion, average 28 day

• Treatment Outcome-Pregnancy Rate

  after study completion, average 10-12 day

• Education Program Satisfaction

  through study completion, average 28 days

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention: Intervention Based on Mindfulness

Behavioral: Interventions Based on Mindfulness

Control

ACTIVE COMPARATOR

Control: Routine clinical procedure

Other: Routine clinical procedure

Interventions

Interventions Based on Mindfulness BEHAVIORAL

Affirmation, Relaxation, Mindfulness, Meditation, Healthy Lifestyle, Quality Life

Intervention

Routine clinical procedure OTHER

Routine clinical procedure

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary infertility,
• Going to undergo IVF treatment,
• Under 45 years of age,
• Having a smart phone or computer

You may not qualify if:

• Participate in any program related to mindfulness
• Prior mindfulness training
• Knowing/doing mindfulness practices beforehand
• Having any psychiatric disorder
• Having any chronic disease
• Disability (hearing/vision etc.)
• Attending less than 80% of the trainings (missing more than 2 Mindfulness trainings)
• Conception during research

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (2)

Dokuz Eylul University

Izmir, 35330, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University

Izmir, 35330, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Figen Yanık, MSc

CONTACT

+905340671318; figen.satkan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 29, 2025
• Study Start: January 31, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)