Stress, PsychologicalNCT02636374
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
A study testing Guided Imagery in people with Stress, Psychological, run by University of Wisconsin, Madison.
Trial summary
The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents. Read more about this study
- Who is it for?
- Ages 13 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 2018
- 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 13 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate
Who cannot join
- Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
About this study
The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.
Read the detailed description
Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions.
The specific aims are:
- to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and
- to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents.
The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.
- Conditions
- Stress, Psychological
- Being tested
- Guided Imagery
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
A fifteen minute recording of gentle music together with soft talking to guide relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery | Experimental | Participants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies. Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9). Receives: Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Stress Measure-9 (PSM-9) score
Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions. The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress. The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002. Each response rests on an 8 point likert scale. For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications. The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice. It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, \& Lalande-Markon, 2009).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startNov 2012
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karla Ausderau, PhD, OTR/L, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636374
- Sponsor's protocol ID
- 2015-0105
- Status last verified
- Nov 2018
- First submitted
- 1 Dec 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
- ClinicalTrials.gov ID
- NCT02636374
- Acronym / sponsor ID
- 2015-0105
- Conditions
- Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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 purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.
Detailed description
Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions.
The specific aims are:
- to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and
- to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents.
The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Behavioral: Guided ImageryParticipants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies. Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9). |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate
Key exclusion criteria (1 listed)
- Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
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 ImageryA fifteen minute recording of gentle music together with soft talking to guide relaxation. | Behavioural | Guided Imagery |
Primary outcome
Change in Psychological Stress Measure-9 (PSM-9) score
Time frame: 4 weeks
Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions. The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress. The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002. Each response rests on an 8 point likert scale. For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications. The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice. It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, \& Lalande-Markon, 2009).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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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.
Karla Ausderau, PhD, OTR/L principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Stress, Psychological, run by University of Wisconsin, Madison.
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 1 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: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Stress Measure-9 (PSM-9) score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.