A Pilot Intervention Study to Promote Functional Health in Women
NCT ID: NCT06235255
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2024-02-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Guided Imagery Intervention
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.
Guided Imagery
The participant will complete the Guided Imagery Intervention for 21 consecutive days.
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.
Cognitive Power Intervention
The investigator with the subject uses the power profile generated by the PKPCT to generate goals that will positively affect functional health.
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.
Combined Guided Imagery and Cognitive Power Intervention
This intervention is a combination of the Guided Imagery Intervention in tandem with the Cognitive Power Intervention
Control Group (No intervention)
The participants are randomly assigned to this group complete all study measures PKPCT and the SF-36v2 measures upon entry into the study and 21 days after entry.
No interventions assigned to this group
Interventions
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Guided Imagery
The participant will complete the Guided Imagery Intervention for 21 consecutive days.
Cognitive Power Intervention
The investigator with the subject uses the power profile generated by the PKPCT to generate goals that will positively affect functional health.
Combined Guided Imagery and Cognitive Power Intervention
This intervention is a combination of the Guided Imagery Intervention in tandem with the Cognitive Power Intervention
Eligibility Criteria
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Inclusion Criteria
2. Between the ages of 18-60
Exclusion Criteria
18 Years
60 Years
FEMALE
Yes
Sponsors
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Seton Hall University
OTHER
Responsible Party
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Phyllis Hansell
Dr. Phyllis Hansell, Professor, Graduate Nursing Department, College of Nursing
Principal Investigators
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Phyllis S Hansell
Role: PRINCIPAL_INVESTIGATOR
Seton Hall University
Locations
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Seton Hall University, College of Nursing
Nutley, New Jersey, United States
Seton Hall University, IHS Campus
Nutley, New Jersey, United States
Countries
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Central Contacts
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References
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Barrett EA. Power as knowing participation in change: what's new and what's next. Nurs Sci Q. 2010 Jan;23(1):47-54. doi: 10.1177/0894318409353797.
Caroselli C, Barrett EA. A review of the power as knowing participation in change literature. Nurs Sci Q. 1998 Spring;11(1):9-16. doi: 10.1177/089431849801100105.
Hansell PS, Hughes CB, Caliandro G, Russo P, Budin WC, Hartman B, Hernandez OC. The effect of a social support boosting intervention on stress, coping, and social support in caregivers of children with HIV/AIDS. Nurs Res. 1998 Mar-Apr;47(2):79-86. doi: 10.1097/00006199-199803000-00006.
Malicki J. The accuracy of dose determination during total body irradiation. Strahlenther Onkol. 1999 May;175(5):208-12. doi: 10.1007/BF02742397.
Giacobbi PR Jr, Stewart J, Chaffee K, Jaeschke AM, Stabler M, Kelley GA. A Scoping Review of Health Outcomes Examined in Randomized Controlled Trials Using Guided Imagery. Prog Prev Med (N Y). 2017 Dec;2(7):e0010. doi: 10.1097/pp9.0000000000000010.
Hong, S.H. (2013) The relationship between perceived health status and health promoting behaviors among nursing students. Journal of Korean Academy Society in Nursing Education 19, 78-86.
Park, S.; Lee, Y.H. (2016) Effects of perceived health status, health attitude, and health concern on health promoting behavior in adults. Journal of Korea Contents Association, 16, 192-202.
Pender, N.J.; Murdaugh, C.L.; Parsons, M.A. (2010) Health Promotion in Nursing Practice, 6ᵗʰ edition; Prentice-Hall: Upper Saddle River, N.J.
Zech N, Hansen E, Bernardy K, Hauser W. Efficacy, acceptability and safety of guided imagery/hypnosis in fibromyalgia - A systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2017 Feb;21(2):217-227. doi: 10.1002/ejp.933. Epub 2016 Nov 29.
Other Identifiers
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ID#2024-514
Identifier Type: -
Identifier Source: org_study_id