The Effect of Breastfeeding Support Provided Via Video-conferencing

Anxiety Disorders Clinical Trial

Official title:

The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929561
• Other study ID #: Breastfeeding Support
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: June 2021
• Source: Kahramanmaras Sutcu Imam University
• Contact: Deniz Akyildiz, PhD
• Phone: 05069851358
• Email: denizbtm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

Infants;

• Born between 37 and 42 weeks

• Without severe congenital anomalies

Mothers;

• A single live birth

• Were 18 years of age or over

• At least primary school graduate

• Did not have a disease that prevents breastfeeding

• Had internet access at home or on the phone

• Could speak and understand the Turkish language.

Exclusion Criteria:

• Situations that cause separation of mother and baby

• Hospitalization of the baby in intensive care

• Inability to answer 3 calls in a video call

• They were determined as those who could not be reached during the home visit for the first and second follow

Related Conditions & MeSH terms

• Anxiety Disorders
• Breastfeeding
• Neonatal Outcomes

Intervention

Behavioral:
• Video-conferencing group
No intervention

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean postpartum maternal anxiety level (mean ± SD)	The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery. Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale. The scale comprises 51 items and 4 sub-dimensions. It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.	at 2 weeks and 4 weeks after delivery
Primary	The mean breastfeeding self-efficacy level	The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form. The scale is likert type and a total score between 14 and 70 is taken from the scale. The higher the score, the higher the breastfeeding self-efficacy.	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-Newborn weight (g)	Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-Hypoglycemia of the newborn	Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-Need for phototherapy	The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-Respiratory morbidity	Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-illness requiring hospitalization	Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-Food intake other than breast milk	Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery
Secondary	Neonatal outcomes-Neonatal death	Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery	at 2 weeks and 4 weeks after delivery