Effectiveness of Virtual Nature-based Intervention During First Stage of Labour

U

University of Oulu

Status

Enrolling

Conditions

Fear of Childbirth
Childbirth Experience
Anxiety
Pain
Stress

Treatments

Other: Virtual nature-based intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05436015
Uoulu_45/2021

Details and patient eligibility

About

Rationale: The birth environment effects on childbirth experience and feelings of security of birthing women. Fear of Childbirth (FOB) is experienced by 6-10% of women in Finland and FOB predicts postpartum depression. Real or artificial views of nature have several positive health effects including reduction of anxiety and stress. Feasible and cost-effective nature-based intervention is being studied in this pilot RCT. Objectives: To develop a virtual nature-based intervention for the delivery ward and to assess its feasibility and effectiveness. The study assesses how the nature-based intervention carried out during the first stage of labour affects the anxiety, fear, stress, pain and childbirth experience of birthing women. The aim is to provide evidence-based information on the feasibility and effectiveness of this intervention. Methods: Sixty women will be randomized into two groups: Nature-based intervention group and control group. All participants will have assessments during first stage of labour in nature-based intervention group before and after intervention and in control group at the same time without intervention. In both groups also 2-6 hours after childbirth, 2 days after childbirth and 2 weeks after childbirth.

Full description

During the piloting and feasibility assessment phase of intervention, the nature-based intervention is tested and its feasibility and preliminary effectiveness on the anxiety, fear, stress, pain and childbirth experience is assessed. Phase II consists of a pilot RCT (Randomized Control Trial) study and a qualitative interview study. The nature-based intervention includes videos filmed in the nature of Northern Finland and takes place during 1st stage of labour before the need for medical pain relief. The pilot phase test group (N=30) will receive a nature-based intervention in addition to standard care during childbirth and the control group (N=30) receives standard care treatment. The study includes parturients (weeks of pregnancy 37+0-41+6) entering delivery ward during active labour. Before childbirth the participants in the study are measured for anxiety, stress, fear of childbirth and pain, and feeling of safety. After childbirth, the childbirth experience is assessed in the deliveryward and before discharge in postnatal ward. Before discharge, postpartum experience with anxiety, fear of childbirth and depression is also measured. During the pilot phase at two weeks, childbirth experience, anxiety and depression are assessed. Data related to childbirth and mental health diagnoses is also collected. The data is analysed using statistical methods. In the pilot phase, the participants in the intervention group (N=5-10) will be interviewed two weeks after childbirth. Thematic interview about the experiences of nature-based interventions of midwives in the delivery room (N=5-10) will also take place. Interviews are recorded and the materials are analysed by inductive content analysis.

Enrollment

60 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • full-term pregnancy (h 37+0 - 41+6)
  • childbirth at active first-stage of labour

Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:

  • severe vision or hearing loss
  • communication is possible only via interpreter
  • childbirth in second stage of labour
  • expected complications during childbirth

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intervention Group
Experimental group
Description:
In addition to usual standard care during childbirth in hospital, the intervention group will receive a virtual nature-based intervention
Treatment:
Other: Virtual nature-based intervention
Control Group
No Intervention group
Description:
The control group receives the usual standard care during childbirth in hospital

Trial contacts and locations

1

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Central trial contact

Minna Manninen

Data sourced from clinicaltrials.gov

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