ParturitionNCT05820958
Intensified Tactile Contact With a Newborn Andt Emotional Transformation of the Mother
A study testing Shantali massage in people with Parturition and Depression, Postpartum, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parturition, Depression, Postpartum
- What is being tested?
- Shantali massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jan 2021to 10 Apr 2022
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Intensified Tactile Contact With a Newborn on the Emotional Transformation of Women After Physiological Delivery
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?
Read the 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.
- Conditions
- Parturition, Depression, Postpartum
- Being tested
- Shantali massage
- Keywords
- postpartum, depression, emotional transformation, tactile contact, massage
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shantali massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group received an intervention in the form of intensified tactile contact of a mother with the newborn. Receives: Other: Shantali massage |
| Control group | No intervention | The control group received no intervention similar to experimental intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1) 3rd day after delivery; 2) within 13th week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start10 Jan 2021
- Primary completion14 Feb 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafał Gnat, The Jerzy Kukuczka Academy of Physical Education in Katowice
- Investigators
- Rafał M Gnat, MSc, Principal investigator, Rafał Gnat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820958
- Sponsor's protocol ID
- 8/2017
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD that underlie results in the publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Intensified Tactile Contact With a Newborn on the Emotional Transformation of Women After Physiological Delivery
- ClinicalTrials.gov ID
- NCT05820958
- Acronym / sponsor ID
- 8/2017
- Conditions
- Parturition, Depression, Postpartum
- Keywords
- postpartum, depression, emotional transformation, tactile contact, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Jerzy Kukuczka Academy of Physical Education in KatowiceUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 20 Apr 2023 (actual)
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Shantali massageThe experimental group received an intervention in the form of intensified tactile contact of a mother with the newborn. |
| Control group | No intervention | –The control group received no intervention similar to experimental intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Shantali massageThe 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. | Other | Experimental group |
Primary outcome
Change in Edinburgh Postnatal Depression Scale
Time frame: 1) 3rd day after delivery; 2) within 13th week after delivery
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.
Change in The Hospital Anxiety and Depression Scale
Time frame: 1) 3rd day after delivery; 2) within 13th week after delivery
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.
Change in Positive and Negative Affect Schedule questionnaire
Time frame: 1) 3rd day after delivery; 2) within 13th week after delivery
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.
Change in Parenting Sense of Competence questionnaire
Time frame: 1) 3rd day after delivery; 2) within 13th week after delivery
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.
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 20 Apr 2023.
- Individual participant dataSharing planned: Yes. All collected IPD that underlie results in the publication
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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.
Rafał M Gnat, MSc principal investigator
Rafał Gnat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shantali massage in people with Parturition and Depression, Postpartum, run by The Jerzy Kukuczka Academy of Physical Education in Katowice at 1 site in Poland.
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 5 inclusion and 6 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 20 Apr 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 Poland. 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?
Change in Edinburgh Postnatal Depression Scale (time frame: 1) 3rd day after delivery; 2) within 13th week after delivery). The study lists 4 primary outcomes in all. 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 20 Apr 2023.