Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02943083 |
| Other study ID # |
7244 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
New York State Psychiatric Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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));
3. 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;
4. 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;
5. 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;
6. 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
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.
