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

Study Overview
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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.

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.

Official Title
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Nature in Hospital - Effectiveness of Virtual Nature-based Intervention During First Stage of Labour: A Feasibility Study and Pilot RCT

Conditions
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Anxiety, Fear of Childbirth, Stress, Pain, Childbirth Experience

Intervention / Treatment
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* Other: Virtual nature-based intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>In addition to usual standard care during childbirth in hospital, the intervention group will receive a virtual nature-based intervention | Other: Virtual nature-based intervention<br>* Virtual nature-based intervention is video with Finnish naturepictures and naturesounds shown from a 75 vertical screen monitor<br>|
| No Intervention: Control Group<br>The control group receives the usual standard care during childbirth in hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety measured with STAI-Y1, change is being assessed | The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most used version of the STAI meter and only it's STATE-A section is utilized. Woman evaluates own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety. | 1) Pre-intervention 2) Two days after childbirth 3) Two weeks after childbirth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) Fear 2) Pain and 3) Feeling of Security with VAS, change is being assessed | VAS (Visual Analogy Scale). The VAS scale allows women to evaluate the intensity of three outcomes (three separate scales); 1) fear 2) pain and 3) feel of security on a 10cm long scale that starts at zero meaning 1) no pain 2) no fear 3) feeling of security at all and ends at 10 representing 1) the worst possible pain 2) the worst possible fear 3) the worst possible feeling of unsecurity. | Pre-intervention and immediately after the intervention | 
| Fear of Childbirth with W-DEQ version Fear of Childbirth W-DEQ version Fear of Childbirth with W-DEQ version B | W-DEQ version B allows women to evaluate experiences around fear of childbirth after the birth. It is currently the most widely used to measure different aspects related to the fear of childbirth. It includes 33 Likert-scale questions (0-5). | Two days after childbirth | 
| Birth Experience with NRS, change is being assessed | The NRS (Numeric rating scale) allows women to evaluate the birth experience from 1 to 10 immediately after birth and two days later. One means a very negative birth experience and 10 means a very positive birth experience. | 1) Two - six hours after childbirth 2) two days after childbirth | 
| Birth Experience with DSS, change is being assessed | The DSS (Delivery Satisfaction Scale) allows women to evaluate the birth experience with 8 questions with a 1-5 scale, 1 meaning very much and 5 not at all | 1) Two - six hours after childbirth 2) two days after childbirth 3) two weeks after childbirth | 
| Maternal Depression with EPDS, change is being assessed | EPDS (Edinburg Postnatal Depression Scale) allows women to estimate symptoms of post-natal depression. Each answer is given a score of 0 to 3 . The maximum score is 30. | 1) two days after childbirth 2) two weeks after childbirth | 
| Stress with physiological measures: Heart rate, change is being assessed | Heart rate (HR, beats per minute, BPM) | Pre-intervention and immediately after the intervention | 
| Stress with physiological measures: Heart rate variability, change is being assessed | Heart rate variability (HRV, milliseconds, ms) | Pre-intervention and immediately after the intervention | 
| Stress with physiological measures: Blood pressure, change is being assessed | Blood pressure: systolic (SBP, mmHg) and diastolic (DBP, mmHg) | Pre-intervention and immediately after the intervention | 
| Stress with physiological measures: Blood pressure variation, change is being assessed | Blood pressure variation (BP variation, mmHg) | Pre-intervention and immediately after the intervention | 
| Stress with physiological measures: Respiration rate, change is being assessed | Respiration rate (RR, breaths per minute BPM) | Pre-intervention and immediately after the intervention | 
| Stress with physiological measures: Baroreflex sensitivity, change is being assessed | Baroreflex sensitivity (BRS, ms/mmHg) | Pre-intervention and immediately after the intervention | 
| Stress with serum cortisol, change is being assessed | Serum cortisol (nmol/l) | Pre-intervention and immediately after the intervention |