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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436015
• Other study ID #: Uoulu_45/2021
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Oulu
• Contact: Minna Manninen
• Phone: +358 50 3084832
• Email: minna.manninen[@]oulu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Childbirth Experience
• Fear of Childbirth
• Pain
• Stress

Intervention

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

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

References & 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. — View 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. — View 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. — View 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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Stress with physiological measures: Heart rate, change is being assessed	Heart rate (HR, beats per minute, BPM)	Pre-intervention and immediately after the intervention
Secondary	Stress with physiological measures: Heart rate variability, change is being assessed	Heart rate variability (HRV, milliseconds, ms)	Pre-intervention and immediately after the intervention
Secondary	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
Secondary	Stress with physiological measures: Blood pressure variation, change is being assessed	Blood pressure variation (BP variation, mmHg)	Pre-intervention and immediately after the intervention
Secondary	Stress with physiological measures: Respiration rate, change is being assessed	Respiration rate (RR, breaths per minute BPM)	Pre-intervention and immediately after the intervention
Secondary	Stress with physiological measures: Baroreflex sensitivity, change is being assessed	Baroreflex sensitivity (BRS, ms/mmHg)	Pre-intervention and immediately after the intervention
Secondary	Stress with serum cortisol, change is being assessed	Serum cortisol (nmol/l)	Pre-intervention and immediately after the intervention