Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother

NCT05820958 | Completed DMC

• 1 other identifier: 8/2017
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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?

Conditions

Parturition; Depression, Postpartum

Keywords

postpartum; depression; emotional transformation; tactile contact; massage

Outcome Measures

Primary Outcomes (4)

• Change in Edinburgh Postnatal Depression Scale

  Psychological questionnaire used to evaluate the change of postpartum depression level. Minimal score - 0 points; maximal score - 30 points. A higher score indicates a higher level of postpartum depression (i.e. higher score = worse). The questionnaire was presented to respondents in an online form.

  1) 3rd day after delivery; 2) within 13th week after delivery

• Change in The Hospital Anxiety and Depression Scale

  Psychological questionnaire used to evaluate the change in the general level of depression and anxiety associated with the hospital stay. Minimal score - 0 points; maximal score - 21 points. A higher score indicates a higher level of depression and anxiety (i.e. higher score = worse). The questionnaire was presented to respondents in an online form.

  1) 3rd day after delivery; 2) within 13th week after delivery

• Change in Positive and Negative Affect Schedule questionnaire

  Psychological questionnaire used to evaluate the change in the levels of positive and negative affective behavior occurring parallelly in the same person within this same time frame The questionnaire consists of two subscales. Subscale 'positive affects': Minimal score - 0 points; maximal score - 50 points. A higher score indicates a higher level of positive affects (i.e. higher score = better). Subscale 'negative affects': Minimal score - 0 points; maximal score - 50 points. A higher score indicates a higher level of negative affects (i.e. higher score = worse). The questionnaire was presented to respondents in an online form.

  1) 3rd day after delivery; 2) within 13th week after delivery

• Change in Parenting Sense of Competence questionnaire

  Psychological questionnaire used to evaluate the change in the level of parental competence of the respondent The questionnaire consists of two subscales. Subscale 'satisfaction': Minimal score - 0 points; maximal score - 54 points. A higher score indicates a higher level of parental satisfaction (i.e. higher score = better). Subscale 'effectiveness': Minimal score - 0 points; maximal score - 48 points. A higher score indicates a higher level of parental effectiveness (i.e. higher score = better). The questionnaire was presented to respondents in an online form.

  1) 3rd day after delivery; 2) within 13th week after delivery

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group received an intervention in the form of intensified tactile contact of a mother with the newborn.

Other: Shantali massage

Control group

NO INTERVENTION

The control group received no intervention similar to experimental intervention.

Interventions

Shantali massage OTHER

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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Jerzy Kukuczka Academy of Physical Education in Katowice: lead

Study Sites (1)

The Jerzy Kukuczka Academy of Physical Education

Katowice, 40-065, Poland

Location

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Rafał M Gnat, MSc

  Rafał Gnat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators were blinded to the results in that way that questionnaires serving as outcome measures were filled up online and results were recorded in the online database. This process was fully automatic. The investigators were unaware of the results until the base was 'opened' after the completion of the study. After the completion of the study, the control group was selected from participants of our previous, observational study based on a non-random, matched sampling method. this procedure was completed by one of the investigators. Then, the data were sent to the outcomes assessor with the names of the groups coded. The assessor was unaware of the roles of the two groups in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSC, associate professor

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 20, 2023
• Study Start: January 10, 2021
• Primary Completion: February 14, 2022
• Study Completion: April 10, 2022
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after the publication
• Access Criteria: IPD will be shared with the following specialists (based on provided documents confirming their professional status and/or list of publications on the topic or similar topics): physiotherapists, psychologists, psychotherapists, obstetrician MDs, pediatrician MDs. Any analyses are allowed provided the original source is clearly indicated in case of any public presentation. Requests will be reviewed and answered by the principal investigator.

Locations

PL (1)