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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anxiety Fear of Childbirth Stress Pain Childbirth Experience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled trial with a two-arm design will be conducted among women entering deliveryward during first stage of labour. Participants are randomized into two groups, an intervention group (N=30) and a control group (N=30). Intervention group members will receive virtual nature-based intervention; video with nature pictures and nature sounds from a 75" vertical screen monitor. Participants receive standard care during first stage of labour in both groups.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Statistician, who is not involved in the study has done block-randomization with variable block-sizes (2,4,6) by StatsDirect program for two groups; an intervention and control group. All study team members and participants will be blind to group allocation with the exception of one research assistant who will not be involved in providing the intervention to the participants or data analysis. Delivery ward staff (midwives) asks informed consent and after receiving it, performs the allocation.

Study Groups

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Intervention Group

In addition to usual standard care during childbirth in hospital, the intervention group will receive a virtual nature-based intervention

Group Type EXPERIMENTAL

Virtual nature-based intervention

Intervention Type OTHER

Virtual nature-based intervention is video with Finnish naturepictures and naturesounds shown from a 75" vertical screen monitor

Control Group

The control group receives the usual standard care during childbirth in hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual nature-based intervention

Virtual nature-based intervention is video with Finnish naturepictures and naturesounds shown from a 75" vertical screen monitor

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No