Health BehaviorNCT06235255
A Pilot Intervention Study to Promote Functional Health in Women
A study testing Guided Imagery, Cognitive Power Intervention and Combined Guided Imagery and Cognitive Power Intervention in people with Health Behavior, run by Seton Hall University at 2 sites in United States.
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.. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Guided Imagery, Cognitive Power Intervention and Combined Guided Imagery and Cognitive Power Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speaks reads and writes English
- Between the ages of 18-60
Who cannot join
- 1. Chronic Illnesses 2 Cognitive Impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Seton Hall University, College of Nursing
Nutley, New Jersey, 07110
Seton Hall University, IHS Campus
Nutley, New Jersey, 07110
About this study
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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Guided Imagery, Cognitive Power Intervention, Combined Guided Imagery and Cognitive Power Intervention
- Keywords
- Functional Health Women
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
The participant will complete the Guided Imagery Intervention for 21 consecutive days.
Cognitive Power InterventionBehavioural
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 InterventionBehavioural
This intervention is a combination of the Guided Imagery Intervention in tandem with the Cognitive Power Intervention
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery Intervention | Experimental | 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. Receives: Behavioral: Guided Imagery |
| Cognitive Power Intervention | Experimental | 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. Receives: Behavioral: Cognitive Power Intervention |
| Combined Guided Imagery and Cognitive Power Intervention | Experimental | 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. Receives: Behavioral: Combined Guided Imagery and Cognitive Power Intervention |
| Control Group (No intervention) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Twenty-one days after the baseline, change will be measured over time
Power to Change in Women
Power as Knowing Participation to change (PKPCT)
Measured: Twenty-one days after the baseline, change will be measured over time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seton Hall University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phyllis Hansell, Seton Hall University
- Investigators
- Phyllis S Hansell, Principal investigator, Seton Hall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235255
- Sponsor's protocol ID
- ID#2024-514
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared and be held in strict confidentiality.
Publications
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.
PubMed 20026728Caroselli 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.
PubMed 9555424Hansell 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.
PubMed 9536191Malicki J. The accuracy of dose determination during total body irradiation. Strahlenther Onkol. 1999 May;175(5):208-12. doi: 10.1007/BF02742397.
PubMed 10356609Giacobbi 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.
PubMed 29457147Hong, 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.
PubMed 27896907
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Intervention Study to Promote Functional Health in Women
- ClinicalTrials.gov ID
- NCT06235255
- Acronym / sponsor ID
- ID#2024-514
- Conditions
- Health Behavior
- Keywords
- Functional Health Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seton Hall UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery Intervention | Experimental | Behavioral: Guided ImageryParticipants 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 | Experimental | Behavioral: Cognitive Power InterventionThe 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 | Experimental | Behavioral: Combined Guided Imagery and Cognitive Power InterventionThe 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 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Speaks reads and writes English
- Between the ages of 18-60
Key exclusion criteria (1 listed)
- 1. Chronic Illnesses 2 Cognitive Impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryThe participant will complete the Guided Imagery Intervention for 21 consecutive days. | Behavioural | Guided Imagery Intervention |
| Cognitive Power InterventionThe investigator with the subject uses the power profile generated by the PKPCT to generate goals that will positively affect functional health. | Behavioural | Cognitive Power Intervention |
| Combined Guided Imagery and Cognitive Power InterventionThis intervention is a combination of the Guided Imagery Intervention in tandem with the Cognitive Power Intervention | Behavioural | Combined Guided Imagery and Cognitive Power Intervention |
Primary outcome
Functional Health in Women
Time frame: At the baseline.
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.
Power to change in Women
Time frame: 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.
Functional Health in Women
Time frame: 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
Time frame: Twenty-one days after the baseline, change will be measured over time
Power as Knowing Participation to change (PKPCT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 20026728Barrett 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.
- Background: PubMed 9555424Caroselli 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.
- Background: PubMed 9536191Hansell 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.
- Background: PubMed 10356609Malicki J. The accuracy of dose determination during total body irradiation. Strahlenther Onkol. 1999 May;175(5):208-12. doi: 10.1007/BF02742397.
- Background: PubMed 29457147Giacobbi 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.
- BackgroundHong, 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.
- Background: PubMed 27896907Zech 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.
- Individual participant dataSharing planned: No. Data will not be shared and be held in strict confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis S Hansell principal investigator
Seton Hall University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery, Cognitive Power Intervention and Combined Guided Imagery and Cognitive Power Intervention in people with Health Behavior, run by Seton Hall University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose L Lopez, PhD (973-761-9334, jose.lopez@shu.ed), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Health in Women (time frame: At the baseline.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235255, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.