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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Stress; Anxiety; Fear of Childbirth; Childbirth Experience
• Intervention / Treatment: Other: Virtual nature-based intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minna Manninen; Phone Number: +358 50 3084832; Email: minna.manninen@oulu.fi

Study Locations

• Finland
  • Oulu, Finland
    • Recruiting
    • Oulu University Hospital
    • Contact: Eila Suvanto, Adj.Prof, MD; Phone Number: +358 40 8085 980; Email: eila.suvanto@ppshp.fi
    • Contact: Minna Manninen, Doc.student; Phone Number: +358 50 3084 832; Email: minna.manninen@oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; Virtual nature-based intervention is video with Finnish naturepictures and naturesounds shown from a 75" vertical screen monitor
No Intervention: Control Group; The control group receives the usual standard care during childbirth in hospital

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital
• Investigators: Study Director: Eila Suvanto, Responsible investigator

Publications and helpful links

General Publications

• Aburas R, Pati D, Casanova R, Adams NG. The Influence of Nature Stimulus in Enhancing the Birth Experience. HERD. 2017 Jan;10(2):81-100. doi: 10.1177/1937586716665581. Epub 2016 Sep 30.
• Berg M, Goldkuhl L, Nilsson C, Wijk H, Gyllensten H, Lindahl G, Uvnas Moberg K, Begley C. Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden. Trials. 2019 Nov 19;20(1):629. doi: 10.1186/s13063-019-3765-x.
• Nielsen JH, Overgaard C. Healing architecture and Snoezelen in delivery room design: a qualitative study of women's birth experiences and patient-centeredness of care. BMC Pregnancy Childbirth. 2020 May 11;20(1):283. doi: 10.1186/s12884-020-02983-z.
• Rouhe H. (2015) Fear of childbirth. Doctoral dissertation. University of Helsinki
• Ulrich, R., Simons, R., Losito, B., Fiorito, E., Miles, M., Zelson, M. (1991). Stress recovery during exposure to natural and urban environments. J. Environ. Psychol. 1991, 11, 201-230.
• Ayerle GM, Schafers R, Mattern E, Striebich S, Haastert B, Vomhof M, Icks A, Ronniger Y, Seliger G. Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial. Trials. 2018 Nov 19;19(1):641. doi: 10.1186/s13063-018-2979-7.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Uoulu_45/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No