Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother
Condition: Parturition; Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test the influence of intensified tactile contact
      between mother and newborn on the direction of the emotional transformation of the mother
      from the physiological, undisturbed delivery to 12 weeks postpartum. The participants will
      deliver intensified tactile stimulation to their newborns in the form of Shantali massage at
      least 2 times a day. Researchers will compare the results obtained in the intervention group
      to the control group in which participants voluntarily did not agree to introduce more
      intensive tactile contact with the child. The main question the study aims to answer is: Is
      the direction of the mother's emotional transformation different after the intensification of
      tactile contact with the newborn in comparison to the control group?
    

Detailed description: 
      Postpartum blues, depression, and psychosis are frequent, burdensome disorders acknowledged
      by WHO. Investigations into their mechanisms, possible causes, and treatments are strongly
      needed.

      OVERALL RESEARCH QUESTION Is the direction of the mother's emotional transformation different
      after the intensification of tactile contact with the newborn in comparison to the control
      group? DESIGN In the study, the non-randomized quasi-experimental design was applied. The
      dependent variables were: the level of emotions in the designated 'negative' domain
      (depression, anxiety, negative affects); the level of emotions in the designated 'positive'
      domain (satisfaction, sense of effectiveness, positive affects). Their values were measured
      with the use of four standardized, self-reported questionnaires two times, i.e. before and
      after the 12-week observation period.

      PARTICIPANTS The experimental group was selected from the local population of pregnant women
      who volunteered to provide experimental intervention to their children after birth. Purposive
      sampling was utilized based on specified eligibility criteria. The intervention (see below)
      started on the 3rd day after birth and lasted until the end of the 12th week postpartum.
      Finally, 43 participants completed the procedure.

      The control group consisted of the participants from our previous, observational study
      matched by age, body mass, and height to the participants of the experimental group. These
      women consciously did not agree to apply the experimental intervention to their children
      during the observation period.

      All participants attended lectures and practical training in a local childbirth school. The
      volume of their education was similar, except for the training of experimental intervention
      (5h in total) which was additionally introduced in the participants of the experimental
      group.

      INTERVENTION In the experimental group, the intervention was applied in the form of
      intensified tactile contact between a mother and the newborn. It was done by means of
      Shantali massage applied at least in 2 sessions a day, 10 min each. Additional, spontaneous
      sessions were allowed. This started on the 3rd day after birth and lasted until the end of
      the 12th week after birth. A total of 169 mandatory sessions should have been provided plus
      spontaneous sessions, if any. No intervention was applied in the control group.

      MEASUREMENTS Four standardized, self-reported psychological questionnaires were used. Their
      text was digitalized and provided to the participants as an online form. All answers were
      automatically transported to the digital database. The base was opened after the completion
      of data collection. Investigators were unaware of the results until that time. They did not
      have the possibility of exerting any influence on the results during the time of
      intervention.

      PROCEDURE After the recruitment, all participants were thoroughly prepared for delivery in
      the one childbirth school. They were all supervised by a medical doctor, psychologist,
      physiotherapist, and nurse at the maternity ward of the one of local hospitals. All
      procedures were similar in the experimental and control groups (except for normal
      individualization of the medical/psychological approach). If no postpartum complications
      occurred, the first measurement of the dependent variables took place on the 3rd day after
      birth. During the intervention period, participants felt free to contact any member of the
      specialists mentioned above as well as anyone of the investigators in case of problems,
      misunderstandings, etc. They started so-called research diaries to record any events that
      might influence their medical/psychological status during the intervention/observation period
      (see eligibility criteria). In the experimental group, participants recorded all intervention
      sessions (both mandatory and spontaneous) they completed. The final measurement of the
      dependent variables values took place within the 13th week after birth.

      STATISTICAL ANALYSIS The internal consistency of the questionnaires was evaluated using the
      Cronbach alpha coefficient. Inter-group differences were analyzed using the appropriate
      parametric or non-parametric tests. Cluster analysis was introduced in order to distinguish
      eventual homogenous subgroups (indicating different directions of postpartum emotional
      transformation) among participants of both experimental and control groups. Correlations
      between values of dependent variables were tested as well.
    

Intervention name(s): Shantali massage
Intervention type(s): Other
Intervention description(s): The tactile contact of a mother with the newborn was intensified by means of Shantali massage applied at least 2 times a day, 10 min. Additional, spontaneous sessions were allowed as well. This started on the 3rd day after delivery and lasted until the end of the 12th week after delivery. A total of 169 mandatory sessions should have been provided plus spontaneous sessions, if any.
The order of application:
face and chest; 4 types of movements 10reps each;
upper extremity; 4 types of movements, 10 reps each (left and right separately);
abdomen; 2 types of movements, 10 reps each;
lower extremity; 3 types of movements, 10 reps each (left and right separately);
back; 2 types of movements, 10 reps each;
final integration; 3 types of movements, 10 reps each.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: In this project, we tested the effect of a single intervention, i.e. intensification of tactile contact between mother and newborn, in the group of volunteers.
The equivalent control group was selected from participants of our previous, observational study based on a non-random, matched sampling method.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: postpartum; depression; emotional transformation; tactile contact; massage