A Pilot Intervention Study to Promote Functional Health in Women
- Conditions
- Health Behavior
- Interventions
- Behavioral: Guided ImageryBehavioral: Cognitive Power InterventionBehavioral: Combined Guided Imagery and Cognitive Power Intervention
- Registration Number
- NCT06235255
- Lead Sponsor
- Seton Hall University
- Brief Summary
The goal of this randomized clinical trial aims to pilot test the effectiveness' of three health promotion interventions for the achievement of optimal functional health in women.. The study interventions include: a Cognitive Power Intervention; a Guided Imagery Intervention and a third intervention that combines the two interventions. The interventions are compared to each other and to a control group in women to improve functional health health status.
- Detailed Description
This pilot intervention study is focused on testing three interventions aimed at the improvement of functional health status in women compared to a control group.function. Regardless of one's age or health status the functional health of a person can be supported and improved. Higher functional health can help to prevent chronic conditions while promoting increased functional health. Higher functional health levels in women can affect not only the person, but also the functional health of their family and friends future patients who may benefit from their role modeling.
A health promoting lifestyle specifically refers to self-directed behaviors that may mitigate adverse health behaviors. According to Pender al (2010) health promoting functional health behaviors consist of six dimensions of health and include: physical activity, nutrition, responsibility, interpersonal relations, spiritual growth and stress management. Despite numerous studies on functional health in women there are no clinical intervention trials testing interventions to improve the level of Functional Health (Park, S. et al (2016); Hong, S.H. (2013); and Yang, N.Y. et al (2019). Power as knowing Participation in Change is a theory that is derived from Rogers, Science of Unitary human Beings. Barrett's (2003) theory focuses on power as freedom to act intestinally which is in sharp contrast to power-as-control. Power-as-freedom comes from and is associated with participating knowingly in life changes (Barrett, 2010). The phases of the theory include Involvement; freedom freedom; choices and awareness (Barrett, 1984). The theory has been operationalized with valid and reliable instrumentation through the Participation in Change Tool (PKPCT).
The Cognitive Power intervention on Health Function uses the PKPCT to determine the subject's power profile to set attainable goals to act intentionally to create specific changes in one's life aimed at the improvement of their health function. Barrett's theory has been used in numerous research studies yet t date none are randomized clinical trials. In the proposed study the subjects power profile is used to effectively deploy their power to best enable the improvement of health function.
The second intervention which is Guided Imagery is a therapeutic technique that aids individuals in therapy to focus on mental images to invoke feelings of relaxation which is based upon the mind-body connection which is considered an important factor a person's overall health Giacobbi, PR (2017). Guided Imagery is considered as complementary and alternative therapy that has been widely used to impact the body as well as the mind. Guided imagery has been used to address pain management, high blood pressure, cancer and other chronic conditions (Zech.N.2017) The literature suggests there is a complementary association between Guided Imagery and Power as Knowing Participation in Change and the outcome of improved health function. This pilot study will help to identify the effects and direction of data which also will be used to further strengthen the future study protocols These data are intended as preliminary data to be included in a large-scale study on minority women with chronic health conditions.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- Speaks reads and writes English
- Between the ages of 18-60
- Chronic Illnesses 2 Cognitive Impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Guided Imagery Intervention Guided Imagery Participants randomly assigned to this group will be provided with a MP3 Player which will have three guided imagery programs. The Guided Imagery Programs include: 1.Relaxation and Wellness; 2. Immune System Imagery and 3. Healing Trauma. The study measures are completed upon entry and 21 days post entry into the study and include: PKPCT and 21 days post entry into the study and include: PKPCT and the SF-36v2. Cognitive Power Intervention Cognitive Power Intervention The participant is randomly assigned to this group completes The Power as Knowing Participation in Change (PKPCT) to determine: 1. Freedom to Act Intentionally; 2. Involvement in creating change; 3.Freedom to act intestinally and 4. My involvement in creating change. The study measures are completed upon entry and 21 days post entry into the study and include: PKPCT and the SF-36v2. Combined Guided Imagery and Cognitive Power Intervention Combined Guided Imagery and Cognitive Power Intervention The participants are randomly assigned to this group completes The Power as Knowing Participation in Change (PKPCT) and the Guided Imagery Intervention as described above. The study measures are completed upon entry and 21 days after entry and include the PKPCT and the SF-36v2.
- Primary Outcome Measures
Name Time Method Functional Health in Women Twenty-one days after the baseline, change will be measured over time SF-36v, Health Survey-Functional Health from the Participants' Perspective
Power to change in Women At the baseline.The tool is nown as the Power as Knowing Participation in Change Tool (PKPCT). Power as Knowing Participation in Change (PKPCT this measure measures power defined as the capacity to participate knowingly in the nature of change as manifest by awareness of choices, freedom to act intentionally and involvement in creating change. this is a seven point semantic differential scale consisting of 12 bipolar adjective pairs and one repeat adjective pairas a retest. The score range is 12 to 84 lower score indicates lower power higher score indicates higher power.
Power to Change in Women Twenty-one days after the baseline, change will be measured over time Power as Knowing Participation to change (PKPCT)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Seton Hall University, College of Nursing
🇺🇸Nutley, New Jersey, United States
Seton Hall University, IHS Campus
🇺🇸Nutley, New Jersey, United States