Effects of noise reduction on physical and mental health of postpartum women

ISRCTN ISRCTN17830643
DOI https://doi.org/10.1186/ISRCTN17830643
Submission date
19/03/2025
Registration date
28/03/2025
Last edited
25/03/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
Hospital noise is a common environmental stressor that can negatively impact the physical and mental health of postpartum women. This study aims to evaluate whether reducing hospital noise levels can improve mental well-being, sleep quality, and physiological recovery in postpartum women.

Who can participate?
Postpartum women aged 22 years or older who have given birth for the first time

What does the study involve?
This study involves assessing the effects of hospital noise reduction on postpartum recovery. Participants are placed in either a noise reduction group, where soundproofing and low-noise medical equipment are used, or a conventional group, where no additional noise reduction measures are implemented. Their anxiety levels, sleep quality, and physiological indicators are monitored during hospitalization to evaluate the impact of noise exposure on maternal health.

What are the possible benefits and risks of participating?
Participants in the noise reduction group may experience improved sleep quality, lower anxiety levels, and better physiological recovery, including reduced inflammation and enhanced hormone balance. There are no known risks associated with noise reduction interventions, as they are non-invasive and designed to create a more comfortable hospital environment.

Where is the study run from?
The Second Hospital of Shanxi Medical University (China)

When is the study starting and how long is it expected to run for?
March 2024 to September 2024

Who is funding the study?
The Second Hospital of Shanxi Medical University (China)

Who is the main contact?
Huiqiang Liu, sxtycyj@163.com

Contact information

Mr Huiqiang Liu
Public, Scientific, Principal Investigator

382 Wuyi Road
Xinghualing District
Taiyuan City
030000
China

ORCiD logoORCID ID 0009-0006-7686-4528
Phone +86 (0)13994200920
Email sxtycyj@163.com

Study information

Study designProspective observational study
Primary study designObservational
Secondary study design
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet
Scientific titleA retrospective study on the effects of hospital noise reduction on physical and mental health in postpartum women
Study hypothesisHospital noise reduction improves postpartum women's mental health, sleep quality, and physiological recovery
Ethics approval(s)

Approved 20/03/2024, Ethics Committee of the Second Hospital of Shanxi Medical University (Room 1119, 11th Floor, Science and Technology Information Building, Second Hospital of Shanxi Medical University, No.382 Wuyi Road, Xinghualing District, Taiyuan City, Shanxi Province, Shanxi, 030000, China; +86 (0)351-3363698; sydeyztjy@163.com), ref: 2024YX088

ConditionPhysical and mental health of postpartum women
InterventionBased on the noise levels recorded in their respective wards, with a cut-off value of 40 dB, patients were divided into two groups: the conventional group and the noise reduction group (NR group):
1. Noise Reduction (NR) Group: Placed in wards with noise reduction measures such as soundproofing, low-noise medical equipment, and environmental modifications.
2. Conventional Group: Standard hospital wards without additional noise reduction measures.

The study aimed to assess the impact of hospital noise reduction on postpartum women’s mental health, sleep quality, and physiological recovery. A total of 150 participants were enrolled and divided into two groups based on noise exposure levels in their respective wards: the Noise Reduction (NR) Group, which received noise reduction interventions such as soundproofing and low-noise medical equipment, and the Conventional Group, which was exposed to standard hospital noise levels. Data was collected over a 3-month period from June to September 2024. Noise levels were continuously monitored, and key outcome measures - including anxiety levels, sleep quality, and physiological indicators - were assessed at multiple timepoints postpartum.
Intervention typeMixed
Primary outcome measure1. Postpartum anxiety: state and trait anxiety levels assessed using the State-Trait Anxiety Inventory (STAI) at baseline (before treatment), postpartum day 1, day 3, and day 4 (one day before discharge)
2. Sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI) at baseline (before treatment) and 4 days postpartum
3. Physiological indicators: CRP levels, prolactin levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse rate, respiratory rate, and body temperature measured using bedside monitors (GE Healthcare, USA) and tympanic thermometers (Exergen, USA) at baseline, postpartum day 1, day 3, and day 4
Secondary outcome measures1. Socio-demographic data: age, education level, marital status, occupation, medical history, previous intensive care experiences, and reasons for current hospitalization are measured using routine hospital documentation at baseline.
2. Noise levels are measured using a sound-level meter (SLM) (NL-22 Type II, RION, Japan) continuously every second over a 3-month period, with data averaged at four key timepoints per day (8:00, 14:00, 20:00, and 2:00).
Overall study start date20/03/2024
Overall study end date30/09/2024

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit22 Years
SexFemale
Target number of participants150
Total final enrolment150
Participant inclusion criteria1. Aged 22 years or older
2. Able to hear, speak, and write
3. Conscious and cooperative
4. Primiparas
5. No major comorbidities
6. Visual analog scale (VAS) score ≤5, assessed within 24 hours postpartum
7. A hospital stay of at least 3 days
8. Complete clinical data
Participant exclusion criteria1. Severe hearing impairment
2. A history of severe psychiatric or neurological disorders
3. Major surgery within the past 6 months
4. Multiple pregnancies or high-risk pregnancies
Recruitment start date30/06/2024
Recruitment end date01/09/2024

Locations

Countries of recruitment

  • China

Study participating centre

The Second Hospital of Shanxi Medical University
382 Wuyi Road
Xinghualing District
Taiyuan City
030000
China

Sponsor information

Second Hospital of Shanxi Medical University
Hospital/treatment centre

382 Wuyi Road
Xinghualing District
Taiyuan City
030000
China

Phone +86 (0)351 3365000
Email sydeyztjy@163.com
Website http://www.sydey.com/
ROR logo "ROR" https://ror.org/03tn5kh37

Funders

Funder type

Hospital/treatment centre

Second Hospital of Shanxi Medical University

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Huiqiang Liu (sxtycyj@163.com). The shared data will include anonymized individual records, and all legal and ethical considerations have been addressed, including consent for data sharing.

Editorial Notes

20/03/2025: Study's existence confirmed by the Ethics Committee of the Second Hospital of Shanxi Medical University.