High Risk PregnancyNCT03419065
Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest
A study testing Relaxation Intervention in people with High Risk Pregnancy, run by Towson University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Risk Pregnancy
- What is being tested?
- Relaxation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2012to 1 Jun 2013
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women on bed rest for high risk pregnancy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest.
Read the detailed description
Women, 18 or older, who consent to this study will participate in a preliminary interview. Study participants will then be trained in the use of progressive muscle relaxation and guided imagery for pregnancy. Participants will be issued a listening device and an audio file and asked to practice it on a daily basis while in the hospital.
Prior to discharge or delivery, the participant will be visited by a member of the research team who will conduct a follow-up interview. The interviews and the relaxation practice sessions will take between 30 and 45 minutes each. The interviews will be audio-recorded, although no identifying information about the participants will be recorded.
At the conclusion of the study, participants will be given a CD of the audio relaxation program and thanked for their participation in the study.
There is minimal risk anticipated in association with participation in this study. All information gained from this study will remain confidential and is for educational purposes only. Participants are entitled to terminate their participation in the study at any time.
It is hoped that the results of this study will provide information about an intervention that may be beneficial to women with high-risk pregnancies. It is also hoped that participation in the exercises will be enjoyable and/or beneficial to you in some way. The results of this study may be used to justify further studies or to influence the type of interventions offered in this or similar settings.
All data collected from the research will remain confidential. Data collected from participants will immediately be assigned an identification number so that no one will be able to identify any individuals in the study.
- Conditions
- High Risk Pregnancy
- Being tested
- Relaxation Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation InterventionBehavioural
Relaxing Music combined with Progressive Muscle relaxation and guided imagery
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Intervention | Other | Women hospitalized on bed-rest for high risk pregnancy participated in Relaxation Interventions. Receives: Behavioral: Relaxation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview
Participants participated in a follow up interview
Measured: 5-7 days
Secondary outcomes (1)
Post-survey
Participants completed a brief post-survey
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Jan 2012
- Primary completion1 Jun 2013
- Study completion1 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Towson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenna Yeager, PhD, OTR/L, Principal investigator, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419065
- Sponsor's protocol ID
- 09-A052R3
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2017
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: de-identified data may be shared through publication but no identifying information will be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest
- ClinicalTrials.gov ID
- NCT03419065
- Acronym / sponsor ID
- 09-A052R3
- Conditions
- High Risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Towson UniversityUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jun 2013 (actual)
- Study completion
- 1 Jun 2013 (actual)
- First posted
- 1 Feb 2018 (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 purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest.
Detailed description
Women, 18 or older, who consent to this study will participate in a preliminary interview. Study participants will then be trained in the use of progressive muscle relaxation and guided imagery for pregnancy. Participants will be issued a listening device and an audio file and asked to practice it on a daily basis while in the hospital.
Prior to discharge or delivery, the participant will be visited by a member of the research team who will conduct a follow-up interview. The interviews and the relaxation practice sessions will take between 30 and 45 minutes each. The interviews will be audio-recorded, although no identifying information about the participants will be recorded.
At the conclusion of the study, participants will be given a CD of the audio relaxation program and thanked for their participation in the study.
There is minimal risk anticipated in association with participation in this study. All information gained from this study will remain confidential and is for educational purposes only. Participants are entitled to terminate their participation in the study at any time.
It is hoped that the results of this study will provide information about an intervention that may be beneficial to women with high-risk pregnancies. It is also hoped that participation in the exercises will be enjoyable and/or beneficial to you in some way. The results of this study may be used to justify further studies or to influence the type of interventions offered in this or similar settings.
All data collected from the research will remain confidential. Data collected from participants will immediately be assigned an identification number so that no one will be able to identify any individuals in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relaxation Intervention | Other | Behavioral: Relaxation InterventionWomen hospitalized on bed-rest for high risk pregnancy participated in Relaxation Interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women on bed rest for high risk pregnancy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Relaxation InterventionRelaxing Music combined with Progressive Muscle relaxation and guided imagery | Behavioural | Relaxation Intervention |
Primary outcome
Interview
Time frame: 5-7 days
Participants participated in a follow up interview
1 secondary outcome
Post-survey
Time frame: 5-7 days
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 1 Feb 2018.
- Individual participant dataSharing planned: No. de-identified data may be shared through publication but no identifying information will be shared
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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.
Jenna Yeager, PhD, OTR/L principal investigator
Towson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Intervention in people with High Risk Pregnancy, run by Towson University at 1 site 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 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Interview (time frame: 5-7 days). 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 1 Feb 2018.