A Pilot Intervention Study to Promote Functional Health in Women

Health Behavior Clinical Trial

Official title:

A Pilot Intervention Study to Promote Functional Health in Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06235255
• Other study ID #: ID#2024-514
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Seton Hall University
• Contact: Jose L Lopez, PhD
• Phone: 973-761-9334
• Email: jose.lopez[@]shu.ed
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Speaks reads and writes English

2. Between the ages of 18-60

Exclusion Criteria:

1. Chronic Illnesses 2 Cognitive Impairment

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Seton Hall University, College of Nursing	Nutley	New Jersey
United States	Seton Hall University, IHS Campus	Nutley	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Seton Hall University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Malicki J. The accuracy of dose determination during total body irradiation. Strahlenther Onkol. 1999 May;175(5):208-12. doi: 10.1007/BF02742397. — View Citation

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, 6?? 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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).
Primary	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
Primary	Power to Change in Women	Power as Knowing Participation to change (PKPCT)	Twenty-one days after the baseline, change will be measured over time