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

NCT05436015 | Unknown

• 1 other identifier: Uoulu_45/2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Fear of Childbirth; Stress; Pain; Childbirth Experience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 1) Fear 2) Pain and 3) Feeling of Security with VAS, change is being assessed

  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

  Two days after childbirth

• Birth Experience with NRS, change is being assessed

  1) Two - six hours after childbirth 2) two days after childbirth

• Birth Experience with DSS, change is being assessed

  1) Two - six hours after childbirth 2) two days after childbirth 3) two weeks after childbirth

• Maternal Depression with EPDS, change is being assessed

  1) two days after childbirth 2) two weeks after childbirth

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Virtual nature-based intervention OTHER

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

Intervention Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

Related Publications (6)

• 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.

  PMID: 27694185 BACKGROUND

• 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.

  PMID: 31744523 BACKGROUND

• 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.

  PMID: 32393297 BACKGROUND

• Rouhe H. (2015) Fear of childbirth. Doctoral dissertation. University of Helsinki

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30454075 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eila Suvanto

  Responsible investigator

  STUDY DIRECTOR

Central Study Contacts

Minna Manninen

CONTACT

+358 50 3084832; minna.manninen@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 28, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)