Clinical trial NCT05436015: Effectiveness of Virtual Nature-based Intervention During First Stage of Labour
Official title: Nature in Hospital - Effectiveness of Virtual Nature-based Intervention During First Stage of Labour: A Feasibility Study and Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Fear of Childbirth
Stress
Pain
Childbirth Experience
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2022-06-28
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Anxiety measured with STAI-Y1, change is being assessed
timeFrame: 1) Pre-intervention 2) Two days after childbirth 3) Two weeks after childbirth
Secondary outcomes:
measure: 1) Fear 2) Pain and 3) Feeling of Security with VAS, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Fear of Childbirth with W-DEQ version Fear of Childbirth W-DEQ version Fear of Childbirth with W-DEQ version B
timeFrame: Two days after childbirth
measure: Birth Experience with NRS, change is being assessed
timeFrame: 1) Two - six hours after childbirth 2) two days after childbirth
measure: Birth Experience with DSS, change is being assessed
timeFrame: 1) Two - six hours after childbirth 2) two days after childbirth 3) two weeks after childbirth
measure: Maternal Depression with EPDS, change is being assessed
timeFrame: 1) two days after childbirth 2) two weeks after childbirth
measure: Stress with physiological measures: Heart rate, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Stress with physiological measures: Heart rate variability, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Stress with physiological measures: Blood pressure, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Stress with physiological measures: Blood pressure variation, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Stress with physiological measures: Respiration rate, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Stress with physiological measures: Baroreflex sensitivity, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
measure: Stress with serum cortisol, change is being assessed
timeFrame: Pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Responsible investigator
name: Eila Suvanto
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Rouhe H. (2015) Fear of childbirth. Doctoral dissertation. University of Helsinki
citation: 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.
citation: 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.