Psychological Stress in PregnancyNCT02943083
Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy
A study testing Relaxation Exercise in people with Psychological Stress in Pregnancy, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The aims of this study are to determine if: 1. during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") can, acutely, reduce maternal stress and affect the fetus (in terms of movement, changes in heart rate and heart rate variability); 2. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress in Pregnancy
- What is being tested?
- Relaxation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 30 Jun 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 18-45 years old,Self-report
- Not smoking during pregnancy,Self-report
- Healthy pregnancy,Self-report
- 26 weeks ± 3 weeks gestation by time of enrollment,Self-report
- Delivering baby at CUMC- CHONY or Allen Pavilion,Self-report
- Receiving prenatal care,Self-report
Who cannot join
- Multi-fetal pregnancy, Selfreport
- Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2-adrenoceptor agonists), Selfreport
- Drinking alcohol or using recreational drugs during pregnancy, Selfreport
- Premature birth (before 37.5 weeks gestation)*, Medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
The aims of this study are to determine if:
- during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") can, acutely, reduce maternal stress and affect the fetus (in terms of movement, changes in heart rate and heart rate variability);
- a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") during pregnancy can have an effect on mitochondria functioning in the placenta through reducing maternal stress during pregnancy (based on our recent findings (Monk et al, 2016));
- the scent will come to function as a conditioned stimulus such that exposure to the scent postpartum will induce greater maternal relaxation, which will have an effect on the mother-infant interaction and infant physiology;
- prenatal maternal exposure to scent combined with abdominal touch will lead to mothers' increased likelihood of utilizing infant massage with a lotion of the same scent postpartum;
- the prenatal ritual and the increased likelihood of engaging in infant massage will lead to a maternal perception of greater mother-infant bonding, attachment and parenting efficacy, and improved maternal mood;
- the prenatal ritual and the increased likelihood of engaging in infant massage will lead to improved performance on the conjugate reinforcement paradigm conditioning task administered to infants at 4 months of age
Read the detailed description
Some women will randomly be assigned to perform the prenatal relaxation ritual both in our lab and at home (Coached Intervention (CI)); some to make prenatal visits to the lab but perform the prenatal relaxation ritual at home only (Home Intervention (HI)); and some to make prenatal visits to the lab but never to perform the prenatal relaxation ritual (Control Group (CG)). In addition, a fourth group of participants will participate in postpartum sessions only (Postpartum Only Group (PO)); the only prenatal experience these participants will have in the laboratory will be the informed consent session. Participants in all four groups (CI, HI, CG, PO) will participate in an informed consent and demographic information session prenatally, during which demographic information and medical history will be collected. At the informed consent and demographic information session, women who participate in prenatal sessions (those in CI, HI and CG) will smell three scent sticks and select their favorite scent. Women in the relaxation ritual groups (those in CI and HI) will utilize the scent in the relaxation ritual during pregnancy. Women in the CG will not be exposed to the scent again until the postpartum period (as detailed in the description of postpartum sessions, below). After the informed consent session, women who participate in prenatal sessions (those in CI, HI and CG) will come into the lab three times for the prenatal sessions, during which participants will be administered questionnaires about background information, moods and stress; collect hair samples for analysis of the stress hormone cortisol; collect blood and saliva samples for analysis of the hormone oxytocin, which plays a role in social interaction, bonding and lactation; and conduct fetal sessions to simultaneously collect maternal and fetal heart rate, as well as maternal blood pressure and respiration and fetal movement. Women in the group that performs the relaxation ritual in the lab (CI) will perform the ritual during the fetal sessions; this will allow assessment of any acute affects of the ritual on mom and fetus. In order to assess if the relaxation ritual during pregnancy can have an effect on mitochondria functioning in the placenta, placentas will be collected from all participants post-delivery and stored for future analyses.
All women will participate in a postpartum session in the hospital within 36 hours of birth. At this session, women in the PO group will have the opportunity to smell the same scent sticks that the other groups smelled prenatally, and select a favorite scent. All women will be given a scented lotion, matching the scent participants were exposed to either prenatally (CI and HI), that participants chose prenatally for postpartum use (CG) or that participants had just selected postpartum (PO). All women will apply the scented lotion and pick up their babies at this session. During this holding period, the investigators will monitor mother and baby heart rate and respiration and baby brain activity via EEG to assess maternal and infant relaxation. Afterwards, all women will be given information on how to use the lotion to give a gentle infant massage.
All dyads will also participate in a 6-week taped diapering and lotion session; the tape will be coded for quality of mother-infant interaction to assess dyadic affect and bonding. Participants will also participate in a session 4-months postpartum where infants engage in a neurocognitive test that assesses memory through a kicking task (conjugate reinforcement paradigm conditioning task). Women will answer questionnaires about their moods, how participants feel about their babies and their babies' daily routines at both of these sessions.
- Conditions
- Psychological Stress in Pregnancy
- Being tested
- Relaxation Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation ExerciseBehavioural
Groups receiving the intervention will be asked to engage in the relaxation protocol every day. Participants will be asked to continue practicing the relaxation protocol for the remainder of their pregnancy. Participants will be instructed to listen to the 7 minute guided muscle relaxation tape and engage in the 3 minute abdominal touch routine in the presence of the scent stick. Participants will be provided with a scent stick of their selected scent to take home. For the duration of the study, participants will be loaned standard headphones and an iPod Touch that contains only the guided progressive muscle relaxation audio recording to facilitate this at-home protocol.
| Study group | Role | What they receive |
|---|---|---|
| Coached Intervention | Experimental | Perform prenatal relaxation exercise in the lab with a coach and at home Receives: Behavioral: Relaxation Exercise |
| Home Intervention | Active comparator | Only perform relaxation exercise at home Receives: Behavioral: Relaxation Exercise |
| Control Group | No intervention | Never performs relaxation routine, attends prenatal assessment sessions |
| Postpartum Only | No intervention | Only attends visits postpartum, never receives prenatal assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire
Improved level of mother-infant bonding as assessed by Postpartum Bonding Questionnaire
Measured: 6 weeks to 4 months postpartum
Secondary outcomes (1)
Change in Maternal Stress Level during Pregnancy as assessed by Perceived Stress Scale
Reduction in stress as operationalized through Perceived Stress Scale
Measured: Change over time from 24 weeks gestation to 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Stress in 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Elizabeth Werner, New York State Psychiatric Institute
- Investigators
- Catherine Monk, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943083
- Sponsor's protocol ID
- 7244
- Status last verified
- Jul 2023
- First submitted
- 13 Oct 2016
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Mother-Baby Bonding Through a Relaxation Routine During Pregnancy
- ClinicalTrials.gov ID
- NCT02943083
- Acronym / sponsor ID
- 7244
- Conditions
- Psychological Stress in Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Oct 2016
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 24 Oct 2016 (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 aims of this study are to determine if:
- during pregnancy, a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") can, acutely, reduce maternal stress and affect the fetus (in terms of movement, changes in heart rate and heart rate variability);
- a progressive muscle relaxation and abdominal touch ritual involving a pleasing scent (i.e. a "relaxation ritual") during pregnancy can have an effect on mitochondria functioning in the placenta through reducing maternal stress during pregnancy (based on our recent findings (Monk et al, 2016));
- the scent will come to function as a conditioned stimulus such that exposure to the scent postpartum will induce greater maternal relaxation, which will have an effect on the mother-infant interaction and infant physiology;
- prenatal maternal exposure to scent combined with abdominal touch will lead to mothers' increased likelihood of utilizing infant massage with a lotion of the same scent postpartum;
- the prenatal ritual and the increased likelihood of engaging in infant massage will lead to a maternal perception of greater mother-infant bonding, attachment and parenting efficacy, and improved maternal mood;
- the prenatal ritual and the increased likelihood of engaging in infant massage will lead to improved performance on the conjugate reinforcement paradigm conditioning task administered to infants at 4 months of age
Detailed description
Some women will randomly be assigned to perform the prenatal relaxation ritual both in our lab and at home (Coached Intervention (CI)); some to make prenatal visits to the lab but perform the prenatal relaxation ritual at home only (Home Intervention (HI)); and some to make prenatal visits to the lab but never to perform the prenatal relaxation ritual (Control Group (CG)). In addition, a fourth group of participants will participate in postpartum sessions only (Postpartum Only Group (PO)); the only prenatal experience these participants will have in the laboratory will be the informed consent session. Participants in all four groups (CI, HI, CG, PO) will participate in an informed consent and demographic information session prenatally, during which demographic information and medical history will be collected. At the informed consent and demographic information session, women who participate in prenatal sessions (those in CI, HI and CG) will smell three scent sticks and select their favorite scent. Women in the relaxation ritual groups (those in CI and HI) will utilize the scent in the relaxation ritual during pregnancy. Women in the CG will not be exposed to the scent again until the postpartum period (as detailed in the description of postpartum sessions, below). After the informed consent session, women who participate in prenatal sessions (those in CI, HI and CG) will come into the lab three times for the prenatal sessions, during which participants will be administered questionnaires about background information, moods and stress; collect hair samples for analysis of the stress hormone cortisol; collect blood and saliva samples for analysis of the hormone oxytocin, which plays a role in social interaction, bonding and lactation; and conduct fetal sessions to simultaneously collect maternal and fetal heart rate, as well as maternal blood pressure and respiration and fetal movement. Women in the group that performs the relaxation ritual in the lab (CI) will perform the ritual during the fetal sessions; this will allow assessment of any acute affects of the ritual on mom and fetus. In order to assess if the relaxation ritual during pregnancy can have an effect on mitochondria functioning in the placenta, placentas will be collected from all participants post-delivery and stored for future analyses.
All women will participate in a postpartum session in the hospital within 36 hours of birth. At this session, women in the PO group will have the opportunity to smell the same scent sticks that the other groups smelled prenatally, and select a favorite scent. All women will be given a scented lotion, matching the scent participants were exposed to either prenatally (CI and HI), that participants chose prenatally for postpartum use (CG) or that participants had just selected postpartum (PO). All women will apply the scented lotion and pick up their babies at this session. During this holding period, the investigators will monitor mother and baby heart rate and respiration and baby brain activity via EEG to assess maternal and infant relaxation. Afterwards, all women will be given information on how to use the lotion to give a gentle infant massage.
All dyads will also participate in a 6-week taped diapering and lotion session; the tape will be coded for quality of mother-infant interaction to assess dyadic affect and bonding. Participants will also participate in a session 4-months postpartum where infants engage in a neurocognitive test that assesses memory through a kicking task (conjugate reinforcement paradigm conditioning task). Women will answer questionnaires about their moods, how participants feel about their babies and their babies' daily routines at both of these sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coached Intervention | Experimental | Behavioral: Relaxation ExercisePerform prenatal relaxation exercise in the lab with a coach and at home |
| Home Intervention | Active comparator | Behavioral: Relaxation ExerciseOnly perform relaxation exercise at home |
| Control Group | No intervention | –Never performs relaxation routine, attends prenatal assessment sessions |
| Postpartum Only | No intervention | –Only attends visits postpartum, never receives prenatal assessments |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women between 18-45 years old,Self-report
- Not smoking during pregnancy,Self-report
- Healthy pregnancy,Self-report
- 26 weeks ± 3 weeks gestation by time of enrollment,Self-report
- Delivering baby at CUMC- CHONY or Allen Pavilion,Self-report
Key exclusion criteria (4 listed)
- Multi-fetal pregnancy, Selfreport
- Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids, chronic-use asthma medications (e.g. beta2-adrenoceptor agonists), Selfreport
- Drinking alcohol or using recreational drugs during pregnancy, Selfreport
- Premature birth (before 37.5 weeks gestation)*, Medical record
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 ExerciseGroups receiving the intervention will be asked to engage in the relaxation protocol every day. Participants will be asked to continue practicing the relaxation protocol for the remainder of their pregnancy. Participants will be instructed to listen to the 7 minute guided muscle relaxation tape and engage in the 3 minute abdominal touch routine in the presence of the scent stick. Participants will be provided with a scent stick of their selected scent to take home. For the duration of the study, participants will be loaned standard headphones and an iPod Touch that contains only the guided progressive muscle relaxation audio recording to facilitate this at-home protocol. | Behavioural | Coached Intervention, Home Intervention |
Primary outcome
Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire
Time frame: 6 weeks to 4 months postpartum
Improved level of mother-infant bonding as assessed by Postpartum Bonding Questionnaire
1 secondary outcome
Change in Maternal Stress Level during Pregnancy as assessed by Perceived Stress Scale
Time frame: Change over time from 24 weeks gestation to 36 weeks gestation
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 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Catherine Monk, Ph.D. principal investigator
Columbia 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 Exercise in people with Psychological Stress in Pregnancy, run by New York State Psychiatric Institute 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 6 inclusion and 4 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 Aug 2023. 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?
Mother-Infant Bonding assessed by Postpartum Bonding Questionnaire (time frame: 6 weeks to 4 months postpartum). 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 Aug 2023.