Postoperative PainNCT07900269
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
A study testing stress ball squeezing in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This project aims to investigate whether the use of a stress ball during the perioperative period, as a non-invasive, drug-free, simple, and easy-to-implement intervention, can reduce the incidence of moderate-to-severe visceral pain within 24 hours after surgery in postpartum women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- stress ball squeezing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for elective cesarean section under neuraxial anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Age: 18-45 years
- Gestational age ≥ 37 weeks
- Willing and able to understand and sign the informed consent form
Who cannot join
- Prior definite diagnosis of severe mental illness, cognitive impairment, or inability to understand pain rating scales and cooperate with the investigator;
- Presence of preoperative chronic pain, or long-term use of analgesic drugs and psychotropic drugs (such as anxiolytics, antidepressants, etc.);
- Hand motor dysfunction (e.g., rheumatoid arthritis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China, 4000000
About this study
Official title: Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section: A Single-center Randomized Controlled Trial
This project aims to investigate whether the use of a stress ball during the perioperative period, as a non-invasive, drug-free, simple, and easy-to-implement intervention, can reduce the incidence of moderate-to-severe visceral pain within 24 hours after surgery in postpartum women.
Read the detailed description
Against the backdrop of persistently high cesarean section rates, postoperative pain has become an increasingly prominent issue. Pharmacological treatment is constrained by breastfeeding safety concerns, and women undergoing cesarean section, as a population susceptible to anxiety, are caught in a vicious cycle of anxiety and pain. Distraction-based interventions have shown favorable effects but have limitations. As a simple and non-invasive tool, the stress ball has been preliminarily shown in other surgeries to have the potential to relieve pain and anxiety; however, its application in the perioperative period of cesarean section remains unexplored. This study intends to conduct a randomized controlled trial to systematically evaluate the effects of squeezing a stress ball during the perioperative period of cesarean section on maternal anxiety and postoperative pain, aiming to provide a safe, economical, and easily scalable non-pharmacological adjunct intervention for enhanced recovery after cesarean section.
- Conditions
- Postoperative Pain
- Being tested
- stress ball squeezing
- Keywords
- anxiety, postoperative pain, cesarean section
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ball squeezingDevice
In the pre-anesthesia room, give the patient a sterilized, palm-sized elastic stress ball. Instruct her to repeatedly "squeeze for 3 s, then relax," optionally with slow breathing or silently counting 1-3, and to use it as needed when anxious. The intervention begins on entry into the pre-anesthesia room and continues until the end of surgery. Four standardized periods are set: (1) after entry into the pre-anesthesia room and completion of pre-intervention data collection; (2) after entry into the operating room and before neuraxial anesthesia; (3) after anesthesia completion and vital-sign stabilization until before fetal delivery; (4) after fetal delivery until before the end of surgery. In each period, continuous intervention lasts 5 min, with a minimum cumulative intervention time of 20 min per participant. After the minimum dose, the parturient may use the stress ball as needed for anxiety or discomfort if it does not interfere with monitoring, anesthesia, or surgery.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | In the pre-anesthesia room, each patient receives a sterilized, palm-sized elastic stress ball. She is instructed to squeeze it tightly for 3 s, then relax, repeating this rhythm; she may add slow breathing or silently count 1-3 and use it as needed when anxious. Intervention starts on entering the pre-anesthesia room and lasts until the end of surgery. Four standardized 5-min periods are set: (1) after entering the pre-anesthesia room and completing pre-intervention data collection; (2) after entering the operating room and before neuraxial anesthesia; (3) after anesthesia is completed and vital signs are stable until before fetal delivery; (4) after fetal delivery until before the end of surgery. The minimum cumulative intervention time is 20 min per participant. After this dose, patients may continue as needed without interfering with vital sign monitoring, anesthesia, or surgical procedures, using the same squeeze-3-s/relax-3-s rhythm. Receives: Device: stress ball squeezing |
| Usual Care Group | No intervention | No stress ball is provided, no additional distraction intervention is administered, and only routine departmental care is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of moderate to severe visceral pain within 24 hours postoperatively
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).The NRS scores for visceral pain at rest and during activity were assessed in parturients at 6 h , 12 h , and 24 h postoperatively. Moderate-to-severe visceral pain was defined as an NRS score of ≥4 (on a 0-10 scale) at any of these time points.
Measured: at 6 hours, 12 hours, and 24 hours after surgery
Secondary outcomes (13)
Frequency of rescue analgesic use within 24 hours postoperatively
Measured: within 24 hours after cesarean section
The area under the curve (AUC) of NRS scores for visceral pain at rest and during activity within 24 hours postoperatively in parturients.
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity)
Measured: at 6 hours, 12 hours, and 24 hours after surgery
Pre- and post-intervention 6-item STAI-S anxiety scores
Six-item Short-Form State-Trait Anxiety Inventory (STAI-S6): the raw sum score ranges from 6 to 24.Higher scores indicate a worse outcome (greater state anxiety).
Measured: Pre-anesthesia , before operating room exit，at 6 hours、12 hours、and 24 hours after surgery
NRS scores for visceral pain at rest and during activity within 24 hours postoperatively (at 6 h, 12 h, and 24 h after surgery)
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
Measured: at 6 hours, 12 hours, and 24 hours after surgery
Hydromorphone equivalent dose within 24 hours after surgery
Measured: within 24 hours after cesarean section
Effective PCIA pump presses within 24 h postop.
The number of effective presses on the PCIA pump can be automatically counted by the pump's backend program.
Measured: within 24 hours after cesarean section
score of pain sensitivity measurement
For the pressure algometer used to measure pain sensitivity, the relevant metric is the Pressure Pain Threshold (PPT). There is no universal minimum or maximum: values are device- and probe-dependent (theoretical minimum 0; e.g., 0-2000 kPa for a 1 cm² probe or 0-4000 kPa for a 0.5 cm² probe). Higher PPT scores indicate a better outcome (lower pressure pain sensitivity), whereas lower scores indicate greater pain sensitivity.
Measured: before intervention in the pre-anesthesia room, immediately upon completion of surgery, and 24 hours postoperatively.
NRS scores for incisional pain at rest and on movement within 24 hours after surgery.
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
Measured: at 6 hours, 12 hours, and 24 hours after surgery
Postoperative adverse reactions
Measured: within 24 hours after cesarean section
AUC of incisional pain NRS scores at rest and on movement within 24 hours after surgery.
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).
Measured: at 6 hours, 12 hours, and 24 hours after surgery
Changes in maternal heart rate during cesarean section.
maternal heart rate (beats/min) wil be measured solely by the operating room monitor
Measured: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Changes in maternal non-invasive blood pressure during cesarean section.
non-invasive blood pressure (systolic/diastolic, mmHg) wil be measured solely by the operating room monitor
Measured: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Changes in maternal pulse oxygen saturation during surgery.
peripheral oxygen saturation (SpO₂, %) wil be measured solely by the operating room monitor
Measured: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900269
- Sponsor's protocol ID
- 20261012
- Status last verified
- Sep 2026
- First submitted
- 14 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section: A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07900269
- Acronym / sponsor ID
- 20261012
- Conditions
- Postoperative Pain
- Keywords
- anxiety, postoperative pain, cesarean section
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
This project aims to investigate whether the use of a stress ball during the perioperative period, as a non-invasive, drug-free, simple, and easy-to-implement intervention, can reduce the incidence of moderate-to-severe visceral pain within 24 hours after surgery in postpartum women.
Detailed description
Against the backdrop of persistently high cesarean section rates, postoperative pain has become an increasingly prominent issue. Pharmacological treatment is constrained by breastfeeding safety concerns, and women undergoing cesarean section, as a population susceptible to anxiety, are caught in a vicious cycle of anxiety and pain. Distraction-based interventions have shown favorable effects but have limitations. As a simple and non-invasive tool, the stress ball has been preliminarily shown in other surgeries to have the potential to relieve pain and anxiety; however, its application in the perioperative period of cesarean section remains unexplored. This study intends to conduct a randomized controlled trial to systematically evaluate the effects of squeezing a stress ball during the perioperative period of cesarean section on maternal anxiety and postoperative pain, aiming to provide a safe, economical, and easily scalable non-pharmacological adjunct intervention for enhanced recovery after cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Device: stress ball squeezingIn the pre-anesthesia room, each patient receives a sterilized, palm-sized elastic stress ball. She is instructed to squeeze it tightly for 3 s, then relax, repeating this rhythm; she may add slow breathing or silently count 1-3 and use it as needed when anxious. Intervention starts on entering the pre-anesthesia room and lasts until the end of surgery. Four standardized 5-min periods are set: (1) after entering the pre-anesthesia room and completing pre-intervention data collection; (2) after entering the operating room and before neuraxial anesthesia; (3) after anesthesia is completed and vital signs are stable until before fetal delivery; (4) after fetal delivery until before the end of surgery. The minimum cumulative intervention time is 20 min per participant. After this dose, patients may continue as needed without interfering with vital sign monitoring, anesthesia, or surgical procedures, using the same squeeze-3-s/relax-3-s rhythm. |
| Usual Care Group | No intervention | –No stress ball is provided, no additional distraction intervention is administered, and only routine departmental care is given. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Scheduled for elective cesarean section under neuraxial anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Age: 18-45 years
- Gestational age ≥ 37 weeks
- Willing and able to understand and sign the informed consent form
Key exclusion criteria (3 listed)
- Prior definite diagnosis of severe mental illness, cognitive impairment, or inability to understand pain rating scales and cooperate with the investigator;
- Presence of preoperative chronic pain, or long-term use of analgesic drugs and psychotropic drugs (such as anxiolytics, antidepressants, etc.);
- Hand motor dysfunction (e.g., rheumatoid arthritis)
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 |
|---|---|---|
| stress ball squeezingIn the pre-anesthesia room, give the patient a sterilized, palm-sized elastic stress ball. Instruct her to repeatedly "squeeze for 3 s, then relax," optionally with slow breathing or silently counting 1-3, and to use it as needed when anxious. The intervention begins on entry into the pre-anesthesia room and continues until the end of surgery. Four standardized periods are set: (1) after entry into the pre-anesthesia room and completion of pre-intervention data collection; (2) after entry into the operating room and before neuraxial anesthesia; (3) after anesthesia completion and vital-sign stabilization until before fetal delivery; (4) after fetal delivery until before the end of surgery. In each period, continuous intervention lasts 5 min, with a minimum cumulative intervention time of 20 min per participant. After the minimum dose, the parturient may use the stress ball as needed for anxiety or discomfort if it does not interfere with monitoring, anesthesia, or surgery. | Device | Stress Ball Group |
Primary outcome
incidence of moderate to severe visceral pain within 24 hours postoperatively
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Numerical Rating Scale (NRS) for pain: minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate a worse outcome (greater pain intensity).The NRS scores for visceral pain at rest and during activity were assessed in parturients at 6 h , 12 h , and 24 h postoperatively. Moderate-to-severe visceral pain was defined as an NRS score of ≥4 (on a 0-10 scale) at any of these time points.
13 secondary outcomes
Frequency of rescue analgesic use within 24 hours postoperatively
Time frame: within 24 hours after cesarean section
The area under the curve (AUC) of NRS scores for visceral pain at rest and during activity within 24 hours postoperatively in parturients.
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Pre- and post-intervention 6-item STAI-S anxiety scores
Time frame: Pre-anesthesia , before operating room exit，at 6 hours、12 hours、and 24 hours after surgery
NRS scores for visceral pain at rest and during activity within 24 hours postoperatively (at 6 h, 12 h, and 24 h after surgery)
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Hydromorphone equivalent dose within 24 hours after surgery
Time frame: within 24 hours after cesarean section
Effective PCIA pump presses within 24 h postop.
Time frame: within 24 hours after cesarean section
score of pain sensitivity measurement
Time frame: before intervention in the pre-anesthesia room, immediately upon completion of surgery, and 24 hours postoperatively.
NRS scores for incisional pain at rest and on movement within 24 hours after surgery.
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Postoperative adverse reactions
Time frame: within 24 hours after cesarean section
AUC of incisional pain NRS scores at rest and on movement within 24 hours after surgery.
Time frame: at 6 hours, 12 hours, and 24 hours after surgery
Changes in maternal heart rate during cesarean section.
Time frame: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Changes in maternal non-invasive blood pressure during cesarean section.
Time frame: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Changes in maternal pulse oxygen saturation during surgery.
Time frame: during surgery: operating room entry, post-CSEA, skin incision, fetal delivery, skin closure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stress ball squeezing in people with Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact He Huang (86+13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of moderate to severe visceral pain within 24 hours postoperatively (time frame: at 6 hours, 12 hours, and 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.