The Effects of Fractal Mindfulness Virtual Reality on Menopause Symptoms

NCT07044284 | Completed

• 1 other identifier: ALondonUni
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to establish the effectiveness of an immersive mindfulness virtual reality intervention using fractal software for women experiencing menopausal symptoms. It was hypothesised that post immersive virtual reality fractal mindfulness intervention would result in higher levels of sexual function, wellbeing and cognitive mindfulness with lower levels of menopause symptoms. It was further hypothesised that in physiological responses, the pulse rate would be lower post intervention per session and an overall reduction in pulse rate post intervention. An electroencephalogram will be used to monitor alpha and beta ratios.

Conditions

Menopause

Keywords

fractal mindfulness; wellbeing; Cognitive mindfulness; Sexual functioning

Outcome Measures

Primary Outcomes (1)

• Menopause symptoms

  This 17 item questionnaire consists of a 4 option (0 not at all, 4 a lot) Likert scale that evaluates menopause symptoms. Example symptoms include difficulty concentrating, loss of interest in sex, pain during sex, and vaginal dryness. Areas are divided into vasomotor symptoms, emotional symptoms, local and sexual symptoms, as well as various physiological symptoms. The Cronbach's alpha is .752. Higher scores indicate higher symptoms of menopause.

  0, 4 and 8 weeks

Secondary Outcomes (3)

• Cognitive mindfulness

  0, 4 and 8 weeks

• Female Sexual Function Index

  0, 4 and 8 weeks

• The Short Warwick Edinburgh Mental Wellbeing Scale

  0, 4 and 8 weeks

Study Arms (2)

Active group

EXPERIMENTAL

Fractal Mindfulness Virtual Reality

Device: Fractal mindfulness recombination

Delayed group

ACTIVE COMPARATOR

Fractal Mindfulness Virtual Reality

Device: Fractal mindfulness recombination

Interventions

Fractal mindfulness recombination DEVICE

Immersive virtual reality using fractal mindfulness software

Active group; Delayed group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Biologically born women which can include trans men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have perceived peri or menopausal symptoms
• Must have normal or corrected to normal hearing and vision
• Must be 18 years or older
• Must have used virtual reality before with no side effects
• Must have a pulse rate of 60 to 80 beats per minute
• Must NOT experience seizures
• Must NOT have coordination difficulties

You may not qualify if:

• Do not have peri or menopausal symptoms
• Have coordination difficulties
• Report having claustrophobia
• Pulse rate higher than 80 at rest
• Have sensitivities to flashing lights
• Are prone to migraine
• Have seizures Are younger than 18 years old

Sponsors & Collaborators

• London Metropolitan University: lead

Study Sites (1)

School of Social Science and Professions

London, N7 8DB, United Kingdom

Location

Related Publications (8)

• Ma J, Zhao D, Xu N, Yang J. The effectiveness of immersive virtual reality (VR) based mindfulness training on improvement mental-health in adults: A narrative systematic review. Explore (NY). 2023 May-Jun;19(3):310-318. doi: 10.1016/j.explore.2022.08.001. Epub 2022 Aug 5.

  PMID: 36002363 RESULT

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 RESULT

• Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and emotion regulation: The development and initial validation of the Cognitive and Affective Mindfulness ScaleRevised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190

  RESULT

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 RESULT

• Prause N, Staley C, Roberts V. Frontal alpha asymmetry and sexually motivated states. Psychophysiology. 2014 Mar;51(3):226-35. doi: 10.1111/psyp.12173. Epub 2014 Jan 27.

  PMID: 24460762 RESULT

• Ciaurriz Larraz AM, Villena Moya A, Chiclana Actis C. Mindfulness-based intervention and sexuality: a systematic review. Trends Psychiatry Psychother. 2024;46:e20210459. doi: 10.47626/2237-6089-2021-0459. Epub 2023 Feb 20.

  PMID: 36803998 RESULT

• Amin SM, El-Gazar HE, Zoromba MA, El-Sayed MM, Awad AGE, Atta MHR. Mindfulness for Menopausal Women: Enhancing Quality of Life and Psychological Well-Being Through a Randomized Controlled Intervention. J Nurs Scholarsh. 2025 Jul;57(4):563-575. doi: 10.1111/jnu.70003. Epub 2025 Feb 24.

  PMID: 39992004 RESULT

• Bies AJ, Blanc-Goldhammer DR, Boydston CR, Taylor RP, Sereno ME. Aesthetic Responses to Exact Fractals Driven by Physical Complexity. Front Hum Neurosci. 2016 May 20;10:210. doi: 10.3389/fnhum.2016.00210. eCollection 2016.

  PMID: 27242475 RESULT

Study Officials

• Samantha Banbury

  London Met Uni

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Model Details: An active and a delayed group

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: June 29, 2025
• Study Start: February 2, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 26, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)