A Pilot Intervention Study to Promote Functional Health in Women
1 other identifier
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 31, 2024
January 1, 2024
11 months
January 22, 2024
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Functional Health in Women
SF-36v Health Survey developed by RAND Corporation measures Functional Health form. The measure the participants' perspective. The 36 item questionnaire developed by the Rand Corporation taps eight health concepts including physical well being; bodily pain; role limitations;emotional problems; energy/ fatigue; general health perceptions. Each item is scored on a Likert scale o 1-4 with a higher score indicative of higher functional health with the possible score range from 36-144.
At the baseline.
Power to change in Women
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.
At the baseline.The tool is nown as the Power as Knowing Participation in Change Tool (PKPCT).
Functional Health in Women
SF-36v, Health Survey-Functional Health from the Participants' Perspective
Twenty-one days after the baseline, change will be measured over time
Power to Change in Women
Power as Knowing Participation to change (PKPCT)
Twenty-one days after the baseline, change will be measured over time
Study Arms (4)
Guided Imagery Intervention
EXPERIMENTALParticipants 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Control Group (No intervention)
NO INTERVENTIONThe 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.
Interventions
The participant will complete the Guided Imagery Intervention for 21 consecutive days.
The investigator with the subject uses the power profile generated by the PKPCT to generate goals that will positively affect functional health.
This intervention is a combination of the Guided Imagery Intervention in tandem with the Cognitive Power Intervention
Eligibility Criteria
You may qualify if:
- Speaks reads and writes English
- Between the ages of 18-60
You may not qualify if:
- \. Chronic Illnesses 2 Cognitive Impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seton Hall University, College of Nursing
Nutley, New Jersey, 07110, United States
Seton Hall University, IHS Campus
Nutley, New Jersey, 07110, United States
Related Publications (9)
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.
PMID: 20026728BACKGROUNDCaroselli 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.
PMID: 9555424BACKGROUNDHansell 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.
PMID: 9536191BACKGROUNDMalicki J. The accuracy of dose determination during total body irradiation. Strahlenther Onkol. 1999 May;175(5):208-12. doi: 10.1007/BF02742397.
PMID: 10356609BACKGROUNDGiacobbi 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.
PMID: 29457147BACKGROUNDHong, 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.
BACKGROUNDPark, 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.
BACKGROUNDPender, N.J.; Murdaugh, C.L.; Parsons, M.A. (2010) Health Promotion in Nursing Practice, 6ᵗʰ edition; Prentice-Hall: Upper Saddle River, N.J.
BACKGROUNDZech 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.
PMID: 27896907BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Phyllis S Hansell
Seton Hall University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Phyllis Hansell, Professor, Graduate Nursing Department, College of Nursing
Study Record Dates
First Submitted
January 22, 2024
First Posted
January 31, 2024
Study Start
February 1, 2024
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 31, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share
Data will not be shared and be held in strict confidentiality.