Effect of mindfulness Kangaroo Care on maternal mental health and preterm infants in Tertiary Care Hospitals in Pakistan
| ISRCTN | ISRCTN39542259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39542259 |
- Submission date
- 27/11/2024
- Registration date
- 09/07/2025
- Last edited
- 24/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Preterm birth, defined as the birth of a neonate before 37 weeks of gestation, is a significant global health concern affecting both infants and the mental health of their parents, particularly mothers. Preterm birth is associated with increased rates of infant mortality and long-term developmental issues, including poor cognitive and mental health outcomes, and reduced quality of life. Beyond these risks to the infant, preterm birth has significant psychological consequences for parents, especially mothers, who experience high levels of stress and emotional strain. Several factors contribute to this parental stress, including the fear of losing their infant, the critical and fragile condition of the newborn, difficulties adjusting to the neonatal intensive care unit (NICU) environment, and the emotional toll of being physically separated from their child immediately after birth. These stressors can lead to the development or exacerbation of mental health issues such as anxiety, depression, and post-traumatic stress disorders in parents, with effects that may persist long after the birth, sometimes for years. For instance, many mothers experience distressing memories of their NICU experience that can last for up to six months postpartum, which can lead to a diagnosis of post-traumatic stress disorder. The current study aimed to integrate mindfulness with kangaroo care to evaluate its effect on maternal mental health and preterm infant outcomes and ensure mental support for maternal mothers for better health outcomes.
Who can participate?
The mothers of preterm infants admitted to the NICU at Ziauddin University Hospital.
What does the study involve?
The study involves a mental health program that will probably improve the psychological and mental well-being of the mothers whose neonates are fighting for their lives in the NICU. Participants will be randomly assigned to either the Mindfulness Kangaroo Care group or the conventional Care group. The intervention will be carried out daily for at least one hour over two weeks. Data will be collected on maternal mental health and infant clinical outcomes.
What are the possible benefits and risks of participating?
The potential benefits include reduced maternal stress and anxiety and improved neonatal health outcomes. The risks are minimal and may include mild discomfort due to prolonged holding during Kangaroo Care.
Where is the study run from?
Ziauddin University, Pakistan
When is the study starting and how long is it expected to run for?
June 2024 to December 2025
Who is funding the study?
Ziauddin University, Pakistan
Who is the main contact?
Shakirullah, Shakirullah.19940@zu.edu.pk, Shakirasf456@gmail.com, shakirlnh456@yahoo.com, a student of PhD at Ziauddin University
Contact information
Public, Scientific, Principal Investigator
Old Sabzi Mandi, Hassan Square
Karachi
75950
Pakistan
 ORCID ID |
0000-0002-7909-9888 |
|---|---|
| Phone | +92 348 4406 556 |
| Shakirullah.19940@zu.edu.pk |
Study information
| Study design | Embedded mixed-methods research study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Qualitative study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effect of mindfulness Kangaroo Care on maternal mental health and preterm infants in Tertiary Care Hospital, Pakistan |
| Study objectives | Hypothesis • Null Hypothesis Ho: There will be no significant effect of mindfulness kangaroo care on maternal mental health and preterm infants as compared to standard care. • Alternative Hypothesis Ha: There will be a significant effect of mindfulness kangaroo care on maternal mental health and preterm infants as compared to standard care. |
| Ethics approval(s) |
Approved 23/05/2025, Faculty of Nursing and Midwifery Departmental Research Committee (Ziauddin University, Karachi, 75950, Pakistan; +92 03484406556; info@zu.edu.pk), ref: 9-15/2022/005 |
| Health condition(s) or problem(s) studied | Improvement of maternal mental health |
| Intervention | This study evaluates a Mindfulness Kangaroo Care (MKC) intervention in comparison to standard care, and the outcome will be measured as maternal mental health and its effect on preterm infant outcomes. The intervention consists of traditional Kangaroo Care integrated with mindfulness practices such as guided breathing exercises and present-moment awareness techniques. Further details are available in the study proposal. |
| Intervention type | Behavioural |
| Primary outcome measure | Maternal mental health outcomes: Stress, anxiety, and depression measured using the Parental Stressor Scale (NICU), General Anxiety Disorder (GAD) Scale, and Edinburgh Postnatal Depression Scale (EPDS) at baseline and 4 weeks post-intervention. |
| Secondary outcome measures | Preterm infant outcomes: 1. Heart rate, respiratory rate and oxygen saturation will be measured from a cardiac monitor and a log sheet that is developed for the study 30 min before, during the intervention and 30 min after the intervention 2. Weight gain recorded in grams using a calibrated digital weighing scale, NICU stay duration from NICU admission to discharge, and incidence of infections, diagnosed based on clinical symptoms and confirmed through diagnostic tests (e.g., blood cultures, CRP levels), are measured using data collected from patient medical records before, at the time of discharge from the hospital, one month after, and then after 2 months |
| Overall study start date | 01/06/2024 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 25 Days |
| Upper age limit | 45 Weeks |
| Sex | Both |
| Target number of participants | Mothers and thier neonates/ Total Participants : 114/57 per group |
| Key inclusion criteria | 1. Mothers aged 18 years old and above with preterm infants (gestational age less than 37 weeks) admitted to the NICU 2. Mothers willing to participate in the MKC intervention for 05 days 3. Mothers who can understand and communicate in Urdu or English |
| Key exclusion criteria | 1. Mothers with a history of severe mental health disorders that could interfere with the MKC intervention (e.g., psychosis) 2. Mothers whose infants are with severe congenital anomalies or life-limiting conditions that may prevent participation in the study 3. Mothers for whom infant death occurs 4. Neonate with worsening of condition |
| Date of first enrolment | 15/01/2025 |
| Date of final enrolment | 01/08/2025 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
Karachi
75950
Pakistan
Sponsor information
University/education
Old Sabzi Mandi, Hassan Square
Karachi
75950
Pakistan
| Phone | +92 2135862937-9 |
|---|---|
| info@zu.edu.pk | |
| Website | https://zu.edu.pk/ |
"ROR" |
https://ror.org/03vz8ns51 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 15/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. In planning there are three expected publications: 1. Scoping Review Paper 2. Interventional Study Final Paper 3. Descriptive Paper |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Shakirullah, Shakirullah.19940@zu.edu.pk, shakirasf456@gmail.com. • Type of data that will be shared: De-identified participant-level data on maternal mental health and infant outcomes. • Timing for availability: Data will be available upon reasonable request after study completion in December 2025. • Consent from participants: Informed consent will be obtained from all participants regarding data sharing. • Data anonymization: All participant data will be anonymized to ensure privacy. • Ethical or legal restrictions: Data sharing will comply with Ziauddin University’s ethical policies and local regulatory requirements. |
Editorial Notes
24/06/2025: Study's existence confirmed by the Faculty of Nursing and Midwifery Departmental Research Committee, Ziauddin University.
