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NCT Number: NCT06725914

The Effect of Kangaroo Father Care Transport on Preterm Infants

This study was planned to investigate the effect of paternal kangaroo care and transport on physiologic parameters, anxiety and paternal attachment in preterm infants.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Nurse's Role Fathers Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Urogenital Diseases

Age range

34 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SELÇUK University

Konya, Selçuklu, 42000, Turkey (Türkiye)

About this study

This study was conducted to determine the effects of paternal kangaroo care and transport of preterm infants on the physiologic parameters of the infant and the anxiety and attachment levels of the fathers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Neonatal related;

  • Born by caesarean section,
  • Born at 34-36+6 weeks gestation,
  • Apgar score of 7 and above at 1 and 5 minutes,
  • Stable and healthy,
  • Infants with a body weight of 1500 g and above were included. It's about the father;
  • Who volunteered to participate in the study,
  • No mental and psychological problems,
  • No communication problems (speech, hearing and severe visual impairment),
  • Fathers who did not carry contact-transmitted diseases (Covid-19, herpes simplex, scabies, etc.) were included.

Exclusion criteria

- Congenital anomalies,

  • Abdominal defects such as ompholocele, diaphragmatic hernia, gastroschisis,
  • Receiving invasive and noninvasive respiratory support,
  • With chest tube and umbilical catheter,
  • Foreign babies and their fathers were ostracized.

Treatment and study plan

Kangaroo Care

Behavioral

Transport practice with paternal kangaroo care in preterm infants

Primary outcomes

  1. Physiological Parameter Monitoring Form-Heart Rate

    Time frame: 3 minutes before the intervention

    Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

  2. Physiological Parameter Monitoring Form-SPO2

    Time frame: 3 minutes before the intervention

    SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

  3. Physiological Parameter Monitoring Form-Body temperature (°C)

    Time frame: 3 minutes before the intervention

    Body temperature (°C) in the Physiologic Parameter Monitoring Form was measured 3 minutes before (T0) the intervention.

  4. Father-Infant Information Form-Paternal characteristics, maternal characteristics and infant characteristics

    Time frame: 15 minutes before the intervention

    Paternal characteristics (age, number of children, educational status, employment status, income status and kangaroo care experience), maternal characteristics (age, educational status, employment status, health problems during pregnancy) and infant characteristics (date of birth, gestational week, gender, birth weight, birth length, birth head circumference, APGAR score, type of anesthesia at birth) were recorded before the intervention.

  5. State Anxiety Scale

    Time frame: 15 minutes before the intervention

    State Anxiety Scale was recorded 15 minutes before the intervention.

  6. Father-Infant Attachment Scale

    Time frame: 15 minutes before the intervention

    Father-Infant Attachment Scale was recorded 15 minutes before the intervention.

Secondary outcomes

  1. Physiological Parameter Monitoring Form-Heart Rate

    Time frame: 3 minutes after the end of kangaroo care (T2).

    Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care

  2. Physiological Parameter Monitoring Form-Heart Rate

    Time frame: 3 minutes after initiation of transport with kangaroo care.(T1)

    Heart Rate in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.

  3. Physiological Parameter Monitoring Form-SPO2

    Time frame: 3 minutes after initiation of transport with kangaroo care.(T1)

    SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.

  4. Fizyolojik Parametre İzleme Formu-SPO2

    Time frame: 3 minutes after the end of kangaroo care (T2)

    SPO2 in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care

  5. Physiological Parameter Monitoring Form-Body temperature (℃)

    Time frame: 3 minutes after initiation of transport with kangaroo care.(T1)

    Body temperature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T1) initiation of transport with kangaroo care.

  6. Physiological Parameter Monitoring Form-Body temparature (℃)

    Time frame: 3 minutes after the end of kangaroo care (T2).

    Body temparature (℃) in the Physiologic Parameter Monitoring Form was measured 3 minutes after (T2) the end of kangaroo care

  7. State Anxiety Scale

    Time frame: 15 minutes before the intervention (T2)

    State Anxiety Scale 15 minutes after the end of the intervention (T2)

  8. Father-Infant Attachment Scale

    Time frame: 15 minutes after the intervention.

    Father-Infant Attachment Scale was recorded 15 minutes after the intervention.

Sponsors and collaborators

Lead sponsor

Zeynep Büşra GÜÇLÜ

Other

Collaborators

  • Selcuk University

Registry information

Official study title

The Effect of Kangaroo Father Care Transport on Physiological Parameters, Anxiety and Paternal Attachment in Preterm Infants: A Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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