Effects of a new mattress and pillow for nightly pelvic girdle pain during pregnancy
| ISRCTN | ISRCTN13438272 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13438272 |
| Secondary identifying numbers | VGRFOU-242761 |
- Submission date
- 20/04/2018
- Registration date
- 27/04/2018
- Last edited
- 20/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Three out of ten pregnant women experience pelvic girdle pain (PGP) and one of ten experiences severe pain. Many of these women have difficulties finding a pain-free sleeping position. This can result in frequent awakenings during the night and daytime tiredness.
A newly developed mattress and pillow have been specially designed for patients with sleep apnea (breathing problems when asleep) so that they avoid sleeping on their back and can achieve a comfortable sleeping position on their side. The newly developed mattress and pillow consists of stretchy foam that shapes around the body. The pillow is separated from the mattress, resulting in a unique possibility to support the shoulder and pelvis when sleeping on the side.
The aim of this study is to investigate whether this mattress and pillow, when added to standard treatment, can decrease nightly pain and sick leave, improve daily function, sleep quality, subjective sleeping time and quality of life, and influence thoughts about pain in pregnant women with PGP.
Who can participate?
Pregnant women with moderate or severe nightly PGP
What does the study involve?
An independent specially-trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a physical examination and filling out questionnaires. All randomized participants will receive standard treatment at the first visit. Standard treatment consists of general information about the condition and anatomy of the back and pelvis. Advice is given on the participant's activities of daily living as well as exercises to do at home that are designed to increase strength in the abdominal (lower body) and gluteal (buttock) muscles. Both groups will be offered the mattress and pillow. Group 1 (the control group) can use the mattress and pillow after 4 weeks of standard treatment alone and group 2 (the intervention group) can use them in addition to standard treatment from the start of the study. Women who are satisfied with the mattress and pillow can borrow them through their pregnancy. The same self-assessed questionnaires of pain, function, sleep quality, subjective sleeping time, sickness leave, quality of life and thoughts about pain will be re-done after 4 and 8 weeks.
In a sub-study, sleep quality will be investigated in some of each group using polysomnography (sleep tracking).
What are the possible benefits and risks of participating?
Possible benefits of participating in the study are that all women get additional treatment as well as standard treatment and that women who are satisfied with the mattress and pillow can borrow them through their pregnancy. It has been confirmed in earlier studies as well as in clinical practice that there are no side effects reported of sleeping with this mattress and pillow. A possible risk is that the exercises that the women do at home can give short-lasting pain.
Where is the study run from?
Sahlgrenska University Hospital in Gothenburg, Sweden
When is the study starting and how long is it expected to run for?
March 2018 to June 2020
Who is funding the study?
The Healthcare Board, Region Västra Götaland (Sweden)
Who is the main contact?
Professor Helen Elden
helen.elden@gu.se
Contact information
Scientific
Sahlgrenska University hospital/ East hospital
Gothenburg
41650
Sweden
Study information
| Study design | Randomized controlled cross-over multicenter trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effects of a new mattress and pillow as adjunct to standard treatment for nightly pelvic girdle pain in pregnant women: a randomised controlled study |
| Study acronym | N/A |
| Study objectives | Null hypothesis: there is no difference in pelvic girdle pain (intensity on a visual analogue scale) in pregnant women after 4 weeks of standard treatment alone and pelvic girdle pain (intensity on a visual analogue scale) in pregnant women after 4 weeks of sleeping on a newly developed mattress and pillow as adjunct to standard treatment. |
| Ethics approval(s) | The Regional ethical review board in Gothenburg, 05/03/2018, 100-18 |
| Health condition(s) or problem(s) studied | Pelvic girdle pain (PGP) in pregnant women |
| Intervention | An independent specially-trained physiotherapist will assess patients who are eligible and willing to participate in the study. This assessment will include a detailed standardized physical examination and collection of baseline data through self-assessment questionnaires. All randomised participants will receive standard treatment at the inclusion visit. Standard treatment consists of general information about the condition and anatomy of the back and pelvis. Adequate advice and practice are also given with respect to the participant's activities of daily living as well as home programme exercises designed to increase strength in the abdominal and gluteal muscles. The newly developed mattress and pillow consists of viscoelastic foam, which shapes around the body. The pillow is separated from the mattress, resulting in a unique possibility to offload the shoulder and pelvis and receive a comfortable sleeping position in a lateral position. Both groups will be offered the mattress and pillow. Group 1 after 4 weeks of standard treatment alone and group 2 (intervention group) as adjunct to standard treatment after randomisation at the inclusion visit. Women who are satisfied with the mattress and pillow can borrow them through their pregnancy. The same assessment and self-assessed questionnaires of pain, function, sleep quality, subjective sleeping time, sickness leave, quality of life and thoughts about pain will be evaluated after 4 and 8 weeks. In a sub study, sleep quality will be investigated in a sub-group of the participants (10 from each group) using polysomnography. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Current primary outcome measure as of 15/09/2021: Intensity of nightly pelvic girdle pain measured on a 100-point visual analogue scale (VAS) every morning for the 8 week trial period Previous primary outcome measure as of 18/03/2021: Participant's score of the intensity of their nightly pelvic pain on a 100-point visual analogue scale (VAS), every morning and their present pelvic pain every evening in a diary _____ Previous primary outcome measure: Participant's score of the intensity of their present pelvic pain on a 100-point visual analogue scale (VAS), every morning and every evening in a diary |
| Secondary outcome measures | 1. The Swedish version of the Pelvic Girdle Questionnaire (PGQ), a questionnaire specific for pelvic girdle pain in pregnancy 2. EuroQoL questionnaire measuring health function and health-related quality of life 3. Pain catastrophizing scale (PCS) a questionnaire measuring thoughts about pain 4. Epworth sleepiness scale (ESS) and subjective sleeping time (number of hours) All questionnaires will be filled at baseline, 4 and 8 weeks. Sleep registration (polysomnography) will be performed during 2-3 nights in 20 participants (10 in each group) |
| Overall study start date | 23/03/2018 |
| Completion date | 15/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 70 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Otherwise healthy 2. Pregnant with singleton fetus and have completed 12-30 gestational weeks 3. Well integrated in the Swedish language 4. Pregnancy-related PGP according to the European Guidelines of diagnosis and treatment of PGP 5. Mean self-reported evening pain intensity of ≥40 mm (on a VAS) in their baseline diary, i.e. 5-7 days before the screening visit |
| Key exclusion criteria | Other pain conditions |
| Date of first enrolment | 15/04/2018 |
| Date of final enrolment | 03/03/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centres
S-413 45
Sweden
S-433 23
Sweden
S-443 42
Sweden
Sponsor information
Research council
Regionens Hus
Göteborg
405 44
Sweden
"ROR" |
https://ror.org/00a4x6777 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2021 | 20/12/2021 | Yes | No |
Editorial Notes
20/12/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
15/09/2021: The following changes have been made:
1. The public title has been changed from "Effects of a newly developed mattress and pillow for pelvic girdle pain during pregnancy." to “Effects of a new mattress and pillow for nightly pelvic girdle pain during pregnancy".
2. The scientific title has been changed from "Effects of a newly developed mattress and pillow for pelvic girdle pain during pregnancy: a randomized controlled cross-over trial." to “Effects of a new mattress and pillow as adjunct to standard treatment for nightly pelvic girdle pain in pregnant women: a randomised controlled study”.
3. The primary outcome measure has been updated.
18/03/2021: The following changes have been made:
1. The primary outcome measure has been changed.
2. The recruitment end date has been changed from 31/03/2019 to 03/03/2020.
3. The plain English summary has been updated.
4. Intention to publish date added.
18/03/2020: The plain English summary was updated.
06/03/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 23/03/2019 to 15/06/2020.
2. The intention to publish date was changed from 31/12/2020 to 15/01/2021.
