AnxietyNCT05436015
Effectiveness of Virtual Nature-based Intervention During First Stage of Labour
A study testing Virtual nature-based intervention in people with Anxiety and Fear of Childbirth, run by University of Oulu at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anxiety, Fear of Childbirth, Stress
- What is being tested?
- Virtual nature-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu
Eila Suvanto, Adj.Prof, MD, +358 40 8085 980, eila.suvanto@ppshp.fi
Minna Manninen, Doc.student, +358 50 3084 832, minna.manninen@oulu.fi
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Fear of Childbirth, Stress, Pain, Childbirth Experience
- Being tested
- Virtual nature-based intervention
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual nature-based interventionOther
Virtual nature-based intervention is video with Finnish naturepictures and naturesounds shown from a 75" vertical screen monitor
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | In addition to usual standard care during childbirth in hospital, the intervention group will receive a virtual nature-based intervention Receives: Other: Virtual nature-based intervention |
| Control Group | No intervention | The control group receives the usual standard care during childbirth in hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: Pre-intervention and immediately after the intervention
Stress with physiological measures: Heart rate variability, change is being assessed
Heart rate variability (HRV, milliseconds, ms)
Measured: 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)
Measured: Pre-intervention and immediately after the intervention
Stress with physiological measures: Blood pressure variation, change is being assessed
Blood pressure variation (BP variation, mmHg)
Measured: Pre-intervention and immediately after the intervention
Stress with physiological measures: Respiration rate, change is being assessed
Respiration rate (RR, breaths per minute BPM)
Measured: Pre-intervention and immediately after the intervention
Stress with physiological measures: Baroreflex sensitivity, change is being assessed
Baroreflex sensitivity (BRS, ms/mmHg)
Measured: Pre-intervention and immediately after the intervention
Stress with serum cortisol, change is being assessed
Serum cortisol (nmol/l)
Measured: Pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Mar 2022
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Eila Suvanto, Study director, Responsible investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436015
- Sponsor's protocol ID
- Uoulu_45/2021
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2022
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27694185Berg 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.
PubMed 31744523Nielsen 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.
PubMed 32393297Rouhe 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.
PubMed 30454075
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nature in Hospital - Effectiveness of Virtual Nature-based Intervention During First Stage of Labour: A Feasibility Study and Pilot RCT
- ClinicalTrials.gov ID
- NCT05436015
- Acronym / sponsor ID
- Uoulu_45/2021
- Conditions
- Anxiety, Fear of Childbirth, Stress, Pain, Childbirth Experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Virtual nature-based interventionIn addition to usual standard care during childbirth in hospital, the intervention group will receive a virtual nature-based intervention |
| Control Group | No intervention | –The control group receives the usual standard care during childbirth in hospital |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual nature-based interventionVirtual nature-based intervention is video with Finnish naturepictures and naturesounds shown from a 75" vertical screen monitor | Other | Intervention Group |
Primary outcome
Anxiety measured with STAI-Y1, change is being assessed
Time frame: 1) Pre-intervention 2) Two days after childbirth 3) Two weeks after childbirth
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.
12 secondary outcomes
1) Fear 2) Pain and 3) Feeling of Security with VAS, change is being assessed
Time frame: 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
Time frame: Two days after childbirth
Birth Experience with NRS, change is being assessed
Time frame: 1) Two - six hours after childbirth 2) two days after childbirth
Birth Experience with DSS, change is being assessed
Time frame: 1) Two - six hours after childbirth 2) two days after childbirth 3) two weeks after childbirth
Maternal Depression with EPDS, change is being assessed
Time frame: 1) two days after childbirth 2) two weeks after childbirth
Stress with physiological measures: Heart rate, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Stress with physiological measures: Heart rate variability, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Stress with physiological measures: Blood pressure, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Stress with physiological measures: Blood pressure variation, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Stress with physiological measures: Respiration rate, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Stress with physiological measures: Baroreflex sensitivity, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Stress with serum cortisol, change is being assessed
Time frame: Pre-intervention and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 27694185Aburas 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.
- Background: PubMed 31744523Berg 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.
- Background: PubMed 32393297Nielsen 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.
- BackgroundRouhe H. (2015) Fear of childbirth. Doctoral dissertation. University of Helsinki
- BackgroundUlrich, 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: PubMed 30454075Ayerle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eila Suvanto study director
Responsible investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual nature-based intervention in people with Anxiety and Fear of Childbirth, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minna Manninen (+358 50 3084832, minna.manninen@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety measured with STAI-Y1, change is being assessed (time frame: 1) Pre-intervention 2) Two days after childbirth 3) Two weeks after childbirth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436015, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.