Clinical trial NCT05820958: Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother
Official title: The Influence of Intensified Tactile Contact With a Newborn on the Emotional Transformation of Women After Physiological Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parturition
Depression, Postpartum
Keywords: postpartum
depression
emotional transformation
tactile contact
massage
Lead sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* first physiological delivery;
* no previous miscarriages;
* normal course of pregnancy;
* normal fetal development confirmed by prenatal ultrasound examination;
* consent to the intervention in the form of intensifying tactile contact with the child during the observation period.

Exclusion Criteria:

* poor health of the child after birth, Apgar score\< 8 points;
* complicated physiological delivery with accompanying poor physical condition of the mother after delivery (deep vein thrombosis, pulmonary embolism, postpartum hemorrhage, inflammation);
* deterioration of the child's health condition preventing contact between mother and child (child's illness, incubation of the child);
* deterioration of the mother's health during the observation period;
* deterioration of the mother's emotional state during the observation due to external factors, such as sudden deterioration of the financial situation, traumatic family events (death, severe illnesses, accidents, etc.), significant deterioration of partnership relations between the child's parents, emotionally burdensome legal problems.
* lack of proper compliance with intervention procedures in the form of intensifying tactile contact with the child, the number of procedures performed \<50% of the recommended number.

Primary outcomes:
measure: Change in Edinburgh Postnatal Depression Scale
timeFrame: 1) 3rd day after delivery; 2) within 13th week after delivery
measure: Change in The Hospital Anxiety and Depression Scale
timeFrame: 1) 3rd day after delivery; 2) within 13th week after delivery
measure: Change in Positive and Negative Affect Schedule questionnaire
timeFrame: 1) 3rd day after delivery; 2) within 13th week after delivery
measure: Change in Parenting Sense of Competence questionnaire
timeFrame: 1) 3rd day after delivery; 2) within 13th week after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: The Jerzy Kukuczka Academy of Physical Education
Study officials:
affiliation: Rafał Gnat
name: Rafał M Gnat, MSc
role: PRINCIPAL_INVESTIGATOR
References: